Model Number N/A |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/10/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.Report soure: (b)(6).
|
|
Event Description
|
It was reported that one screw was loose and did not fit on the shaft of the blade during a procedure.The procedure was completed with another product.No adverse events have been reported as a result of the malfunction.
|
|
Event Description
|
It was reported that one screw was loose and did not fit on the shaft of the blade during an oral surgery.The procedure was completed with another product.No adverse events have been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.
|
|
Manufacturer Narrative
|
One screw was returned with a damaged head.The item and lot numbers are confirmed to match the label.Dimensional testing was not completed due to damage to the screw heads or for attempted use with the driver.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined due to the inability to dimensionally measure the product because of the product damage.A possible gauge issue was identified.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 is available at the time of this report.
|
|
Search Alerts/Recalls
|