It was reported that during a rotator cuff repair, the multifix wire of the suture loader broke while trying to load the suture legs through the snare loop.This left the sutures out of the device, with no ability to insert them.So, the surgeon passed the suture through the snare pulling the sutures by hand.The procedure was successfully completed without a significant delay.No 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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H10: h2, h3, h6.The reported device, used in treatment, was returned for evaluation.There was no relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number 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 an repeated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that mishandling the device can result in failure.Clinical evaluation was completed and concluded that per complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Based on the information provided, the breakage of the first suture passer did not occur inside of the patient.Additionally, it was reported, while the surgeon was using a second device, the same issue occurred.As a result, the surgeon used a change in surgical technique by using his hands to pull the sutures.According to the report, the procedure was successfully completed without a significant delay.Since no other complications were reported, no further clinical/medical assessment is warranted at time.Should any relevant medical information be provided, this compliant will be re-assessed.Visual evaluation shows a device returned deployed.The implant is not available.The device is intended for single use and functional test is not possible.The complaint was not confirmed.Factors that could have contributed to the reported event include: (1) incorrect suture loading.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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