Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
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 reports: 0001825034-2021-02696.Medical products: item#: 909857, ziptight ankle syn sys-ss; lot#: 029210.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as hospital discarded the implant.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 an ankle procedure two implants were used and were unable to be implanted in the patient.The first implant, became unusable while tensioning and implant tore off the end of the switch.The second implant, became unusable when part of the implant fell through the patient¿s fibula during tensioning.Subsequently the physician had to drill a new hole.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02696-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were 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 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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Search Alerts/Recalls
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