Medical device manufacturer, Synthes GmbH, has issued a medical device safety alert concerning its Inserter for Titanium Elastic Nails [Part number: 359.219; Lot numbers: 3163015, 8878816].
According to the manufacturer, the affected lots of the Inserter for Titanium Elastic Nails (TEN) may have the potential for breakage during use. The manufacturer is not requiring an immediate return of affected product(s) as the removal of the TEN Inserter would prevent the performance of emergency surgery.
If an Inserter for TEN breaks during use, there is the potential for surgical delay while an alternate trauma set is located to complete the procedure. In a worst case scenario, if the Inserter for TEN breaks during use, the breaking pieces may cause damage to surrounding structure and/or injury to user.
The manufacturer will recall the affected products in phases.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 06 March 2015