DEPUY MITEK LLC US LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE
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Model Number 210711 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284); Device Contamination with Body Fluid (2317); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2022 |
Event Type
malfunction
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Event Description
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This is report 3 of 3 for (b)(4).It was reported by a healthcare professional in india that during a bankart repair procedure, it was observed that three lupine loop rapide anchor w/orthocord devices were bent at the tip and beyond use.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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Manufacturer Narrative
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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.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Manufacturer Narrative
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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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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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.Investigation summary: the complaint device was received and evaluated.Upon visual inspection, the shaft has no structural anomalies, the anchor is broken.Rests of biological matter can be observed over the anchor and the suture.A manufacturing record evaluation was performed for the finished device 8l94713 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, this complaint cannot be confirmed.The customer reported a bent anchor, however, the returned anchor was found broken instead of bent.The possible root cause for the broken anchor can be attributed to procedural variables, such handling of the device or product interaction during procedure, bending force may was applied to the device at the moment of insertion; as per ifu 109002: do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.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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Event Description
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It was reported by a healthcare professional in india that during a bankart repair procedure, it was observed that the lupine loop rapide anchor w/orthocord device was bent at the tip and beyond use.During in-house engineering evaluation, it was determined that the anchor was broken and a black biological matter could be observed over the anchor pieces and suture.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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Manufacturer Narrative
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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.Udi: (b)(4).Investigation summary : the complaint device was received and evaluated.Upon visual inspection, the shaft has no structural anomalies, the anchor is broken.A black matter can be observed over the anchor pieces and suture.An ftir analysis was conducted to determine the composition of the black matter found, the result of the analysis was is a biological-based material, therefore we can relate this matter to the use of the anchor.A manufacturing record evaluation was performed for the finished device 8l94713 number, and no non-conformances were identified.As part of depuy synthese mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint cannot be confirmed.The customer reported a bent anchor, however, the returned anchor was found broken instead of bent.The possible root cause for the broken anchor can be attributed to procedural variables, such handling of the device or product interaction during procedure, bending force may was applied to the device at the moment of insertion; as per ifu: do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese 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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Search Alerts/Recalls
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