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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 08/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during a knee arthroscopy, a set meniscus mender ii disposable presented problems at the beginning and broke (outside of patient).Procedure was completed without any delay, with the same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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Internal complaint reference (b)(4).B5: updated.H10 h3, h6: the reported device was received for evaluation.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.A visual inspection of the returned device found that it is not in its original packaging.Both hubs of the suture loops were returned, but only one shaft/loop assembly.They are separated between the shaft and the hub.There is debris on the device and the monofilament loop is bent and twisted.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.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.
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Event Description
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It was reported that during a knee arthroscopy, the needles from the meniscus mender set broke before being used in the patient.The surgeon experienced some difficulty but continued the procedure with the same device.No surgical delay or patient injuries were reported.
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Search Alerts/Recalls
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