Model Number N/A |
Device Problems
Failure to Cut (2587); Patient Device Interaction Problem (4001)
|
Patient Problem
Unspecified Tissue Injury (4559)
|
Event Date 03/31/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Telephone number: (b)(6).
|
|
Event Description
|
It was reported that during surgery, the device was taking the skin irregularly.It was reported that there was patient impact/harm but there are no additional details regarding the harm.Due diligence is complete and there is no additional information available.
|
|
Manufacturer Narrative
|
This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the device was out of calibration at the 0 reading.The thickness control shaft, bearings, and spring seal were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.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.G2 country: south korea.
|
|
Event Description
|
There is no additional information available regarding the malfunction.
|
|
Search Alerts/Recalls
|