It was reported that during procedure, the loop retriever of the set meniscus mender was disassembled between head and shaft when the package was opened.The procedure was completed with a s+n back-up device.No delay was reported, and no other complications were reported.
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H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that both meniscal suture loops were detached from their handles.The rest of the set was in good condition.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause was associated with device design.Corrective actions have been implemented for this failure mode.
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