Catalog Number 00596104010 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returning to zimmer biomet for evaluation as the product has been discarded.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
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Event Description
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It was reported that during the trialing process of an initial total knee arthroplasty, the articular surface provisional instrument fractured into two pieces when the surgeon bumped it with a hammer.No patient impact or adverse events have been reported as a result of the malfunction.It was reported that no further information is available.
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Event Description
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No further event information at time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to failure of the operator to follow instructions.It was reported that the device was struck with a hammer and the instructions for use indicate that breakage can occur if the instrument is subject to high loads or impact.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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