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 11/02/2023 |
Event Type
malfunction
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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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Event Description
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This is report 1 of 4 for (b)(4).It was reported by the healthcare professional in china that during a meniscal repair procedure on 11/2/2023, it was observed that the plate on the truespan 24 degree peek device could not fix the meniscus after deployment.Changed to another three 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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted 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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, the sleeve was cut to see the internal condition; as a result, the implants and suture were not received along with the needle.The needle was deformed.When test its functionality, it was also observed that the trigger was loose, in that there was no tension on the handle from the spring.Therefore, the gun was opened, and it was found that the initial part of the trigger was broken and disconnected from the firing spring, it indicates that the internal mechanism of the handle was not working.A manufacturing record evaluation was performed for the finished device lot number: 203l261, and no nonconformances were identified.Based on the visual results, this complaint cannot be confirmed.The process of the truespan have two phases where the deployment gun is checked (the step of applier functional testing and the implant system routing check), this test guaranties the applier has been properly assembled and is functional.This information corresponds to a process control, and it is the appropriate document to use to guarantee that this issue can¿t have happened during manufacturing process.No information was provided on how this failure has occurred or specifications of the procedure, therefore a definitive root cause could not be determined.The possible root cause for the reported failure could be related when not inserting the needle to the proper depth for deployment which have caused that the implant not be deployed as intended which could cause stuck.When attempted to fire the implant against the tissue, it can feel a resistance and excessive force could have caused stress on the handle thus causing the handle mechanism to break.However, it cannot be conclusively affirmed.As per ifu, for the needle insertion, it is necessary use a calibrated probe, measure the width of the meniscal tissue to help insert into the joint.Set the adjustable depth stop to minimize tissue penetration depth.Also, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging tissue.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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