ZIMMER BIOMET, INC. OFFSET END CAP 12X0MM FFSET; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 11/08/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Report source: foreign country: (b)(6) customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that during surgery, the nail end cap could not be removed.Therefore, the instrument could not be positioned in the nail.As a result, the end cap remains implanted.The surgery was delayed 1.5 hours due to the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|