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.Additional narrative: udi: (b)(4).Investigation summary: the device was received and evaluated.Upon visual inspection, it could be observed that the anchor is bent, also the sutures are tensioning from the handle's groove, the shaft has no structural anomalies.A manufacturing record evaluation was performed for the finished device lot number: 9l10959, and no non conformances were identified.A manufacturing investigation was performed; as a result, there is a 100% control at different stages of production.Anchor tightening, by a torque meter + anchor/shaft assembly + anchor/shaft gap with a measuring gauge.Also, 100% visual control: check that no degradation on the suture and on the anchor is present.There has been a closer look on the in-process controls.The results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the document reviewed.The sample was deeply reviewed by scanning electron microscope (sem); as a result, the 2 samples show evidence of plastic deformation.The anchor is made of polylactic acid and polyglycolic acid (pla + pga = poly (lactide-coglycolide)).When the component of this device, is exposed to temperatures over 21 degrees c, its structure gets compromised as it tents to lose mass, it provides flexibility to the polymer chains producing a decrease in the degree of crystallinity of the structure and the microhardness values causing these types of deformations (zuluaga, 2013).These damages have typical characteristics of material exposed to temperatures higher than recommended, however this cannot be conclusively determined.Please review attachment isr-10212022-0677.Based on the results, this complaint can be confirmed.The possible root cause of this failure can be attributed to the devices were exposed to temperatures higher than the recommended while in stock.Temperatures over 21 degrees celsius and the pre-set tension on the sutures may lead to a bent/broken anchor.No further information has been provided to help in the determination of the root cause for this failure.As per ifu: store in a cool dry place.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
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It was reported by a healthcare professional in (b)(6) that during a bankart repair surgery on (b)(6) 2022, it was observed that the lupine loop rapide anchor w/orthocord device was bent at the tip upon opening its package.During in-house engineering evaluation, it was determined that the anchor was bent.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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