Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The product has been returned to zimmer biomet for investigation.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 a knee instrument was returned fractured.There is no additional information available at this time.
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Event Description
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No further event information available at the 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.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6 complaint sample was evaluated and the reported event was confirmed.Visual exhibits signs of repeated use and the post feature has fractured off.Device history record (dhr) were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.Supplier dhr¿s were reviewed for deviations and/or anomalies and one non-conformance was found.A definitive root cause cannot be determined.Evaluation of the returned device identified the fracture was consistent with the tasp fractures analyzed in zrm_wa_0496_18.The zrm identified that the common failure modes for the tasp devices include either bending overload or low cycle fatigue culminating in bending overload as evident by the presence of hackle marks, river lines and striations features on the fracture surface.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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