|
Model Number N/A |
Device Problem
Disassembly (1168)
|
Patient Problem
Tissue Damage (2104)
|
Event Date 09/12/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
|
|
Event Description
|
It was reported that patient underwent an ulnar collateral ligament reconstruction surgery.After drilling a hole in bone, the surgeon attempted to insert the suture using preloaded device.However, after the second throw of the suture, the needle popped off.The surgeon removed the anchor and utilized another kit to finish the procedure.
|
|
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.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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.
|
|
Search Alerts/Recalls
|
|
|