MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 228152 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
Event Type
malfunction
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Event Description
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This is report 2 of 2 for (b)(4).It was reported by the healthcare professional in china that during a meniscal repair procedure on (b)(6) 2023, it was observed that the plate on the truespan 24 degree peek device could not fix the meniscus after deployment.Changed to another one to continue the surgery but the same problem happened again.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.Device was used for treatment, not diagnosis.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.
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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 mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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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 mitek or its employees that the report constitutes an admission that the device, 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 two devices were returned to mitek for evaluation without lot information.Mitek then conducted visual inspection of device received.Visual analysis of the first device, the implants and suture were deployed, they were not in the needle.There are no anomalies or structural damage on the outside of the device.It was verified that the pusher shaft tip is sliding out completely the applier needle, no obstruction or difficulties while actioned.A manufacturing record evaluation was performed for the finished device lot number, and no nonconformances were identified.According with the visual inspection result, this complaint can be confirmed.We cannot discern a root cause for user to have experienced this issue.Based on the meniscal repair technique guide, it is necessary to choose the portal which most easily allows the delivery needle to be inserted perpendicular to maximize your ability to reach and position your anterior meniscal repair site.Also, it is possible that when pull the trigger while pressing hard against the bone behind the meniscus and there is not enough space for the anchor to deploy between the meniscus and bone, so when then pull the needle tip back the anchor just pulls out with it and cannot fix the meniscus.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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