Catalog Number LV01333 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that the awl broke during surgery.The tip was retrieved and an alternate was used to complete the case.There were no reported patient impacts.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The dhr was reviewed.There were no nonconformances or temporary deviations associated with this failure on this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.The device was not returned for further investigation nor were pictures submitted by the user.Therefore, a definitive root cause was unable to be determined.Review of complaint history for pn lv01333, ln 311460, identified 0 additional complaints for the same or similar issue in the 12 months leading up through the complaint date to the present.Additionally, 0 total other complaints were found for the same ln 311460.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Event Description
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It was reported that the awl broke during surgery.The tip was retrieved and an alternate was used to complete the case.There were no reported patient impacts.
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Search Alerts/Recalls
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