Model Number 7209485 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that during a procedure, the loop retriever of two (2) meniscus mender needle sets disassembled between head and shaft when the packages were opened.It is unknown how the procedure was completed.No surgical delay nor patient complications were reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that during a procedure, the loop retriever of two (2) meniscus mender needle sets disassembled between head and shaft when the packages were opened.It is unknown how the procedure was completed.No surgical delay nor patient complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.It was determined the device contributed to the reported event.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of risk management found that the anticipated risk level is no longer adequate.A review of the device drawings found a stress relief collar is now attached at the connection between the shaft and the hub of the suture capture loop.This design change was implemented as a result of a corrective action initiated to address the reported issue.The complaint was confirmed, and the root cause was associated with device design.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A corrective action for this failure mode is in place.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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