This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: udi:(b)(4).Investigation summary: the product has not returned to depuy synthes mitek, however a photo was provided for review.The photo investigation revealed that 4.5 healix br anchor w/ocord was broken at the distal end of the anchor.Foreign matter was visible at the tip.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the 4.5 healix br anchor w/ocord would contribute to the complained device issue.Based on the investigation findings, the potential cause for the broken anchor can be traced to off axis insertion and levering during insertion.As per ifu- 109362 inserting the awl less than the specified depth, axial misalignment or levering with the anchor upon insertion, may result in anchor fracture, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
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It was reported by the healthcare professional in china that during a rotator cuff repair procedure on (b)(6)2 024, it was observed that the anchor on the 4.5 healix br anchor w/ocord device was broken off, removed all the broken parts.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
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