If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during the unknown surgery, opened the packing(did not use), noted the anchor was missing and suture was loose (as the photo shows).Another device was used to complete the surgery.The device was received and evaluated.Visual observations reveals that the plastic sleeve that holds the anchor was found retracted to the full open position, due to this, the anchor was released.The suture was reviewed, it is impregnated with biological rests.The anchor is missing.The photos provided by the customer are showing the same results.A manufacturing record evaluation was performed for the finished device 3l05856 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, and considering that the device was not returned with its original packaging, this complaint cannot be confirmed.The possible root cause can be attributed to the handling of the device, the operator could have slidden the plastic sleeve that holds the anchor at the moment of opening the device, leading to a pre-released anchor.As per ifu 107414 the steps for proper anchor release are provided.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the anchor was missing and the suture was loosed on the micro quick anchor plus with ethibond suture device upon opening its package.During in-house engineering evaluation, it was determined that the suture on the device was impregnated with biological residues.Another like device was used to complete the surgery.There were no adverse patient consequences reported.No additional information was provided.
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