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 08/16/2023 |
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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This is report 1 of 2 for (b)(4).It was reported by a healthcare professional in new zealand that during an unknown procedure on (b)(6) 2023, it was observed that the anchor on the truespan meniscal repair system peek 24 degree device did not set properly after firing.Changed to another one but the same problem occurred.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary photos and the complaint device were received and evaluated.Upon visualization of the photos returned, it was observed that the device is shown in a bag, it was noted that neither the plates nor the suture were visible.Based on the visual findings of the photos provided, this complaint cannot be confirmed.Two devices without lot identification were returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of the first device received.The device was received and evaluated.When performing the visual inspection, it could be observed that the plates and the suture were not returned; the needle is deformed; therefore, this complaint cannot be confirmed.The red trigger was found in a normal shape.The trigger was pressed several times without restriction.A manufacturing record evaluation was performed for the finished device 146l362 number, and no non-conformances related to the reported complaint condition were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.A possible root cause for the issue experienced by the customer can be attributed to the procedural variables, such handling of the device or product interaction during procedure; it is possible that the depth penetration of the tissue was not maintained, therefore, the plates did not fully trespass the soft tissue and were pulled out along with the device, also, the possible root cause of needle¿s condition, when it was inside the joint and the needle tip was maneuver to desired location for optimal approximation, it was leveraged, therefore causing stress and a mechanical deformation.However, it cannot be conclusively affirmed.As per ifu, it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.Also, it is important to fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.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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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: 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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