Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00840107203, flexible cannulated reamer 6.5 mm diameter, 62656833.(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 report: 0001822565 - 2018 - 05871.
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Event Description
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It was reported that during an elbow arthroplasty procedure, two (2) reamers became stuck in the intramedullary canal during use.While trying to remove the reamers, they both fractured.There was a forty-five minute delay to the procedure due to the issue.No additional information is made available.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned devices shows the tip had disassembled from the shaft.Dhr was reviewed and no discrepancies were found.A definitive root cause cannot be determined.F 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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Event Description
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No additional information is available to report at this time.
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Search Alerts/Recalls
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