It was reported that during an unspecified procedure, the loop retriever of the set meniscus mender ii disposable, was disassembled between head and shaft when the package was opened.The procedure was successfully completed without delay using a back-up device.No patient complications were reported.
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Internal complaint reference (b)(4).H10 h3, h6: the reported device was returned to the designated complaint unit for independent evaluation.There was a relationship found between the device and the reported event.A complaint history review found 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 suture loop is disassembled between the head and the shaft.No needles were returned, and only one suture loop was received.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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