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Model Number N/A |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Information (3190)
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Event Date 06/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that when a nurse opened the component's packaging for a total knee arthroplasty operation, it was found that the double sterile blisters were broken.Another femoral was used for the operation.No patient consequences were reported as a result of the malfunction.Attempts to obtain additional information are in progress, however no further information is available.
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Manufacturer Narrative
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Reported event is confirmed as the packaging is damaged.The femoral component and it's packaging was returned and from the evaluation of the returned product determined that, the inner and outer cavities are cracked and the outer exhibits some transit damage.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.The cracked cavities damage can be caused by the outside forces during transit or the forces due to the implant.As the outside carton showing damage, the transit may be the cause of the reported issue.So the root cause for the reported issue attributed to be transit damage.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.
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Search Alerts/Recalls
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