Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Foreign: event occurred in (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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
|
It was reported that the wire of the ziploop toggleloc fractured.Attempts have been made and additional information on the reported event is unavailable at this time.No adverse events have been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
A couple of sutures and a ti button were provided for evaluation; visual inspection identified the suture is broken.Additional information does not change the root cause of the previous investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No additional information reported.
|
|
Search Alerts/Recalls
|