MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 228152 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
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) 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 switzerland that during a meniscal repair procedure on (b)(6) 2023, it was observed that the anchor on the truespan 24 degree peek device was jammed and did not release properly.Another like device was used to complete the procedure with a delay of three minutes.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 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.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: h4: the device manufacture date was unknown in the initial report and has been updated accordingly.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of the device.The complaint device was received and evaluated; visual inspection reveled that the device was returned with the first plate deployed.Second plate was still attached in the needle.The applier needle, shaft suture and trigger did not show structural anomalies.The device was tested using a soft tissue simulator; the device performed as intended on second plate, it was seated as expected, no restrictions were noted.A manufacturing record evaluation was performed for the finished device lot numbe and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the functional test result, this complaint cannot be confirmed, since the device passed the functional test without any problem, it is not possible to determine a root cause for the issue experienced by the customer.At this point in time, 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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