Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant devices - vanguard distal femoral peg set 2 catalog #: 183099 lot #: 368860.Report source - foreign: event occurred in japan.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event; please see all reports associated with this event: 0001825034-2023-00957.
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Event Description
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It was reported that during a knee arthroplasty when the packaging for the femoral pegs was opened, the inner sterile bags were identified to be torn.The pegs were not used in the procedure.No adverse events were reported as a result of this malfunction.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual evaluation of the returned devices identified that the inner sterile pouches were broken into multiple pieces.However, evaluation of the outer pouches found no damage, and therefore sterility was not breached.The device history records were reviewed and no discrepancies were identified.As the condition of the devices was conforming when it left zimmer biomet, a definitive root cause could not 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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Search Alerts/Recalls
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