MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 228152 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
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.H10 additional narrative: udi: (b)(4); incomplete.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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It was reported by the healthcare professional in china that during a meniscal repair procedure on (b)(6) 2024, it was observed that the truespan 24 degree peek device could not fire 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.H4: the device manufacture date was reported as unknown on the initial report; and has been updated 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 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.H10 additional narrative: 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.Upon visual inspection of the photo, it was observed that the device trigger is in its full retracted position, however with the photo provided it is not possible to identify a failure/damage in the device.A manufacturing record evaluation was performed for the finished device 156l016, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The overall complaint was unconfirmed as the photographs attached are insufficient to draw a conclusion about the reported event.Based on the investigation findings, it has been determined that 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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary = > the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned device.The device was received and evaluated.When performing the visual inspection, it could be observed that the device does not show structural anomalies, the white sleeve was removed to verify the presence of the plates, however they were not returned for evaluation as well as the suture.To test its functionality, the red trigger was pressed several times and it worked as intended, it was verified that the pusher shaft slide without anomalies.The overall complaint was unconfirmed as the observed condition of the truespan 24 degree peek would not contribute to the complained device issue.Based on the investigation findings and since both plates were not returned for physical evaluation, it was conclude that there is no enough evidence to adjudicate a root cause for the issue experienced by the customer.Therefore it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
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