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Catalog Number 228302 |
Device Problems
Degraded (1153); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
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 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.Device was used for treatment, not diagnosis.Reporter is a j&j sales representative.The device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4) incomplete.
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Event Description
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It was reported by the sales rep that during an anterior cruciate ligament (acl) repair procedure, it was discovered that the button on the arthroscopic pusher/cutter device was jamming, making it difficult to cut the suture.There were no delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted 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.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.D4, udi: lot number the device lot number was unknown the initial medwatch report.The lot number has been identified as 23d05 and the udi has been updated accordingly.Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted 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.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.Investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the device found the device in used condition as expected.When performing the functional test, the pusher jammed, and the suture was not cut.By reviewing the blade, it was found dullness of cutting edges.It is not unreasonable that the condition identified in evaluation would contribute to a dull condition.Therefore, we are able to confirm dullness with damage observed, as this kind of evidence indicates repeated use of the device.The lifecycle requirements of the device are event related and depend on the use in clinical practice, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of device would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life as there were external forces to which the cutting edge may was subjected, resulting in metal fatigue and dulling of the cutting edge.Per the ifu recommends to visually inspect the instrument and check for damage and wear; verify that all cutting edges are free of nicks and have a continuous edge; verify that moveable parts have smooth movement without excessive play; inspect that locking mechanisms fasten securely and close easily; and verify that long, thin instruments are free of bending and distortion.A manufacturing record evaluation was performed for the finished device 23d05, and no non-conformances were identified.The potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes 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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