Model Number 110024773 |
Device Problems
Difficult or Delayed Activation (2577); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Cmp- (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00842 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was reported that the anchor did not deploy during the procedure.Another instrument was used to complete the procedure.No adverse events have been reported as a result of the malfunction.No further information is available.
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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.D4 ¿ two device ids were provided by the customer/reporter; it is unknown which exact device was the complaint product, it is one of the following: item#: 110024773, lot#: 740160.Manufacture date: 31 january 2020.Sterile expiry date: 31 january 2025.Udi: (b)(4).Or item#: 110040954, lot#: 923950.Manufacture date: 27 may 2021.Sterile expiry date: 27 may 2026.Udi: (b)(4).Visual examination of the returned products identified the first device depth sleeve has fractured.The part has been cycled and has the sutures and the anchor within sleeve tubing.The second device has been cycled twice and no anchors were returned.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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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Search Alerts/Recalls
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