Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical product: 00780600510-retractor 1-64533728.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02306.Product has been received by zimmer biomet and the investigation is in process.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 the tips broke on the retractors during surgery.All of the pieces were retrieved.No delay to the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual review of retractors identified the following: the tip had fractured and the fractured piece was not returned.There were nicks and gouges consistent with use on the tips of these instruments.Retractor (ln 64533728) has a potential field age of approximately 4 months, and retractor (ln 62219387) has a potential field age of approximately 7.5 years.Review of the zimmer biomet's device history records and receiving inspection report identified no deviations or anomalies during manufacturing.Supplier's device history records were not reviewed as the devices exhibit wear and tear consistent with use over a field age of 4 months, and 7.5 years respectively.Additionally, review of the raw material certificate in the rir confirmed that the materials utilized were conforming to specifications.A definitive root cause cannot 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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Event Description
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No additional information on reported event.
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Search Alerts/Recalls
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