Model Number N/A |
Device Problem
Device Operational Issue (2914)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacture history has not been provided for review.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Expiration date ¿ ni.Manufacture date ¿ ni.
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Event Description
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During a right hip fracture nail fixation procedure, the nail would not attach to the jig.Another nail was used to complete the procedure with minimal delay and no patient injury.
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Manufacturer Narrative
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Visual review of the returned device shows some staining which was likely a result of the decontamination process.Furthermore, there does not appear to be damage to the nail.A dimensional analysis was completed on the proximal end of the nail that connects with the jig.Two (2) of the slots on the proximal end of the nail measured undersized as well as the opening that connects to the jig.The dimensional analysis confirmed the complaint.The device is considered to be nonconforming as dimensions were out of spec with no visible damage that would have caused the nonconformities.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause was determined to be a manufacturing issue.Corrective and preventive actions have been initiated as a result of the nonconformance.F 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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