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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 Date 08/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-03876.Concomitant medical products: drill pin and screw inserter, item# 00590102100, lot# 64103203.Report source: (b)(6).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 during the surgery, when putting the pin into the patient, the distal end of the screwdriver shaft fractured into two pieces.The two pieces were found and no pieces fell into the patient¿s body.Another pin inserter from another set was opened and the second one also fractured.All pieces were found and no pieces remain in the patient¿s body.There was no delay in the surgery.The case was finished with another instrument.There is no additional information 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 is being submitted to relay additional information.Visual evaluation of the returned both drill and screw inserters shows damages related to use and fractured tip.Device was submitted for further analysis.Analysis determined that the fracture is caused by overload.Crack initiated at outer diameter and propagated into the inner diameter of the instrument.Also, both instrument exhibits the same type of failure mode.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.Sem analysis found the fracture is related to overload not manufacturing issue.Also, this analysis found material is consistent with prints.Per package insert instrument/provisional use, care and sterilization states not to subject instruments to high loads and/or impact as breakage can occur.However, 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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Search Alerts/Recalls
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