Model Number N/A |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported that during a distal biceps repair, the device did not pull the tendon into the socket fully.There were no reported patient consequences as a result of the malfunction.No additional information is available.
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Event Description
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No further information available.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no related manufacturing deviations or anomalies were identified.Root cause was unable to be determined.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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