It was reported that during a meniscus repair surgery the set meniscus mender ii disposable was opened and it was found damaged, the handle was separated from the shaft.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
H10 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.An analysis of the customer provided images confirmed the state of the device prior to return.The second meniscal loop suture was missing in the picture, and both handles were detached.A visual inspection revealed that the device was returned opened, with one loop meniscal suture missing.The handles of both loop meniscal sutures were present, but they were replaced in the packaging upside down.The metal of the handles indicated that the loop shafts had detached.The other four sutures were returned in their original state.There was no debris present.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.A review of the drawing found that found that the set was specified to be shipped in protective packaging, with both loop meniscal sutures inserted fully into the handles.The complaint was confirmed and the root cause was associated with device design.
|