MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 228152 |
Device Problems
Device-Device Incompatibility (2919); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2024 |
Event Type
malfunction
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Event Description
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It was reported by the healthcare professional in australia that during a bilateral bucket handle repair procedure on (b)(6) 2024, it was observed that 5 x truespan 24 degree peek devices failed.It was reported that three devices popped out on tensioning and the second back stop would not deploy on two devices.Another two like devices were used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.Report 2 of 5 for (b)(4).
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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) 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The investigation has been updated to reflect the correct information: investigation summary: according to the information provided, it was reported that ¿5 x truespan failed in a bilateral bucket handle repair attempt.Three popped out on tensioning and two the second back stop would not deploy.Used two more to complete the repair adequately.Hospital threw away the failed implants unfortunately¿.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (9l56767), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Correction h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.
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Search Alerts/Recalls
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