MEDOS INTERNATIONAL SÃ RL TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 228152 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2023 |
Event Type
malfunction
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Event Description
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It was reported by a healthcare professional in china that during a meniscal repair procedure on (b)(6)2023, it was observed that the shaft on the truespan meniscal repair system peek 24 degree device broke.Another like device was used to complete the procedure.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.H10 additional narrative: udi: (b)(4).D4: the expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.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.Investigation summary = > a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo shows the device over the table.The device is in used condition.The device's shaft shows broken upwards.A manufacturing record evaluation was performed for the finished device 9l74280 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.Based on the investigation findings, the reported complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an excessive manipulation of the device, tilting movements of the applier needle while it was inserted causing the shaft to be broken, however, this cannot be conclusively determined.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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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.H10 additional narrative: investigation summary = > the complaint device was received and evaluated.On visual inspection, the device is in used condition.The device's shaft shows broken upwards.The covering sleeve was removed to verify the needle condition, it was found that the needle is detached from the shaft.The broken end shows metal stress evidence.A manufacturing record evaluation was performed for the finished device 9l74280 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.Based on the investigation findings, the reported complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an excessive manipulation of the device, tilting movements of the applier needle while it was inserted causing the shaft to be broken, however, this cannot be conclusively determined.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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Search Alerts/Recalls
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