It was reported that during an arthroscopic labrum repair with rotator cuff tear procedure, when bridged in normal use, the metal tip of the inserter broke off and remained inside the anchor.The metal piece was not retrieved from the patient's anatomy.No delay reported.Surgery was completed using the same device with no other complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The reported device, used in treatment, was not returned for evaluation.However, x-ray images were provided.There was a relationship found between the reported incident and the reported device, based on the images provided.A review of the device history records for the device 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 instructions for use found that mishandling the device can result in failure.Without the reported product a visual and functional evaluation cannot be performed; however, customer¿s complaint can be confirmed based on the x-ray images provided.They show an foreign material inside the patient's shoulder.Factors that could have contributed to the reported event include: excessive force, misalignment of implant or inserter during and after insertion.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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