MEDOS INTERNATIONAL SARL 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 04/14/2024 |
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.
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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: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photos upon the photo visualization, it was noted that the red trigger is activated and the first plate is already deployed.The overall complaint was unconfirmed as the photograph provided is not representative of the reported complaint condition.Based on the investigation findings and since the first plate was already deployed, it was conclude that there is no enough evidence to adjudicate a root cause for the issue experience 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 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.H4: the device manufacture date was unknown udi: (b)(6).
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Event Description
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It was reported by the sales rep in china that during a meniscal repair surgical procedure on (b)(6) 2024 the truespan 24 degree peek device could not fire.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences 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.The product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection and functional test 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 first plate was found to be deployed, no anomalies were detected in it.The second plate was still attached to the needle.To test its functionality, the applier needle was introduced into a soft tissue simulator, the red trigger was fully squeezed and the second plate released as intended.No failure was identified.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 no deployment issues were detected, 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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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.D4, h4: the expiration date and device manufacture date have been added.
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Search Alerts/Recalls
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