Catalog Number 110003451 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: cat #: 010002736 - ball hex drvr for insr hndl, cat #: 010000664 - pps ltd acet shell 54f lot #: 7286498.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02164 and 0001825034-2022-02166.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.
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Event Description
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It was reported that the lock on the impactor cross threaded into the cup and the drive broke while trying to disengage.There were no health consequences or impact to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h4; h6 visual examination of the returned product identified the devices were stuck together so no functional analysis was completed.There was an indentation on the shaft of the inserter and the tip has a roll on the threads.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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