Events

Alerte De Sécurité sur SynReam Medullary Reamer Head Ø 8.5 mm

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Synthes.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-12-24
  • Date de publication de l'événement
    2013-12-24
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131224.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: synthes synream medullary reamer head ø 8.5 mm medical device manufacturer, synthes, has issued a medical device safety alert concerning its synream medullary reamer head ø 8.5 mm [part no.: 352.085; lot no.: 15392 through 19396, 24613 through 25347, 1448284 through 2087630]. the manufacturer is initiating a product recall related to the referred part and lot numbers of the synream medullary reamer head ø 8.5 mm. the possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material. there are two potential patient harms associated with the breakage of the reamer head. significant surgical delays (greater than 15 minutes) could result due to the presence of a reamer head that breaks during use. secondary incisions and x-rays may be required to aid in and confirm device removal. in addition, the reamer head is composed of non-implant grade material therefore the retention of non-implant grade material can result in minor bone damage where additional intervention is optional but not required. in a worst case scenario there is the potential for an adverse tissue reaction to occur. in this situation the patient will be symptomatic requiring treatment. the manufacturer advises affected users to take the following actions:- return all unused affected sets to the manufacturer for credit or replacement. inspect their inventory and remove all affected devices from use. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 december 2013.

Device

SynReam Medullary Reamer Head Ø 8.5 mm
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes SynReam Medullary Reamer Head Ø 8.5 mm
  • Manufacturer
    Synthes

Manufacturer

Synthes