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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Code Available (3191)
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Event Date 10/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).The complaint was confirmed as product was returned.Two flexible reamers are returned for evaluation.Lot 63134901 reamer was fractured and an unknown pin remains inside the cannulation.Material composition confirmed devices were conforming to specifications.Sem analysis concluded "based upon visual examination of fracture artifacts, both reamer shafts likely fractured as a result of torsional overloads." dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.A definite root cause cannot be determined with the information provided.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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It was reported that during ulnar preparation for an elbow arthroplasty procedure, the reamer fractured inside patient's bone.No fractured pieces fell into the patient, and the patient did not retain any foreign bodies.A new 7mm reamer was used to complete the procedure with minimal delay to procedure.No further patient consequences reported.No additional information is available.
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Search Alerts/Recalls
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