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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 Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 498003, bmp sleeve grip crimper, mmx1915.The 498003, bmp sleeve grip crimper, mmx1877.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00753, 0001825034-2018-00755.
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Event Description
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It was reported that the instrument was found broken.No further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and corrected information.The complaint samples were evaluated and the reported event was confirmed through physical evaluation.The returned devices underwent fracture analysis and hardness testing.All devices were identified to be fractured near the base, however lot mmx1877 (finished goods item (b)(4), lot 336650) was also identified to be missing a hinge pin.All visible fracture artifacts for the three (3) devices suggest a bending overload failure, however, the devices were in conformance with specifications.The device history records were reviewed and no discrepancies were identified.Based on available information, 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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: three crimper product identifications were reported in conjunction with this event.It is unknown after follow-up attempts which instrument fractured.The information for the second and third liner are as follows: item name: bmp sleeve grip crimper, catalog number: 498003, lot number: 120160, manufacture date: nov 20, 2015.Item name: bmp sleeve grip crimper, catalog number: 498003, lot number: 513220, manufacture date: jun 13, 2016.
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Search Alerts/Recalls
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