MEDOS INTERNATIONAL SARL TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE; SOFT-TISSUE ANCHOR, BIOABSORBABLE
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Model Number 228152 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2022 |
Event Type
malfunction
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Event Description
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It was reported by a healthcare professional in china that a meniscal repair procedure on (b)(6) 2022, it was observed that the needle on the truespan meniscal repair system peek 24 degree was deformed.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information could be 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.Udi: (b)(4).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 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.Investigation summary : the complaint device has not been returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the device shaft was observed deformed; therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 9l46759, and no nonconformances were identified.The photo does not provide enough evidence to determine root cause.Without physical evaluation of the device reported, we cannot establish a root cause for the issue experienced by the customer.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure.As per ifu, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging soft tissue.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.
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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 actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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.Investigation summary: the complaint device was received and evaluated; visual inspection reveals that the needle is bent.The plastic sleeve was removed to verify the presence of both plates, the plates were not found inside the applier needle and they were not returned.A manufacturing record evaluation was performed for the finished device 9l46759 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection and the functional test results, this complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an excessive manipulation of the device, tilting movements of the device while it was inserted causing the needle to be deformed, however this cannot be conclusively determined.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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