Catalog Number 231220124 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D4/h4: the provided lot number could not be located within the system, udi and date of manufacture are unknown.D10: associated product information, part number (lot number): 30510003 (unknown).E1: full establishment name: (b)(6).G2: foreign - the event occurred in south africa.The customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 an initial procedure, the depth gauge fractured.The correct surgical technique was used.No complications, injuries, surgical interventions, or foreign bodies were retained due to this malfunction.The case was completed without any adverse outcomes to the patient.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.Correction to d4.It was confirmed through additional information that lot number initially provided was incorrect; therefore, lot number updated to unknown.If 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 further event information is available at the time of this report.
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Event Description
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No further event information is available 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.The reported event is unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If 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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Search Alerts/Recalls
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