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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 01/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) 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.Concomitant medical products: part: 31-301311, arcos con sz a hi 60mm trl, lot: unk, part: 11-301919, arcos 19x250mm intlkng dist, lot: unk.Report source: (b)(6).
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Event Description
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It was reported that the 3.5mm hex screwdriver broke off inside the cone proximal body trial whilst trying to remove it from the definitive sts stem.As the trial was now stuck to the definitive stem the whole construct had to be removed from the patient.Removal and reimplantation caused a 60 minute delay in surgery.Attempts have been made and no further information has been provided.
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Event Description
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Attempts have been made and 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 information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10 complaint sample was evaluated and the reported event was confirmed.An arcos 3.5mm hex drive, part # 31-301852 from lot z18l2492, was returned and evaluated against the complaint.Visual inspection confirmed the tip of the hex driver to be fractured.The fractured tip was not returned.The shaft is worn such that wear rings are present around the shaft.Discoloration spots were observed on the shaft and handle.The instrument is sporadically nicked and scratched.The device has a potential field age of approximately 1 year and 10 months.Device history record (dhr) was reviewed and no discrepancies were found.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 further event information available at the time of this report.
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Event Description
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No further information 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.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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