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Model Number 7209485 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2020 |
Event Type
malfunction
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Event Description
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It was reported that during meniscus repair surgery, when opening the package, the set meniscus mender ii was found damaged, the shaft and the handle were disassembled.The procedure was completed without delay using a s+n backup device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H2: additional information: h6: health effect - clinical and impact code h3, h6: the reported device was returned to the designated complaint unit for independent evaluation.It was determined the device contributed to the reported event.A complaint history review found no similar reported events.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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not 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.The hubs of both loop retrievers are fractured from the shafts.The shafts and snares were returned with the other device components.A review of the customer provided image finds the complaint device, with the hubs of the loop retrievers fractured from the shafts on the smith+nephew product box.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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Search Alerts/Recalls
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