MEDOS INTERNATIONAL SARL RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
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Model Number 232447 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2022 |
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.Udi: (b)(4).Reporter is a j&j employee.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 that this was an unknown surgery performed on (b)(6) 2022.It was reported by the affiliate in japan that during an unknown surgery on (b)(6) 2022, it was observed that when the surgeon pulled the white suture on the rigidloop adjustable cortical implant, standard device inside the patient¿s body to adjust the length of the loop, the suture felt caught in the middle of adjusting the loop, and the length of the loop could not be shortened any further.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 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.Investigation summary: according to the information received, it was reported that ¿when the surgeon pulled the white suture inside the patient¿s body to adjust the length of the loop, the suture felt caught in the middle of adjusting the loop, and the length of the loop could not be shortened any further.¿ the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (9l40676), and no non-conformance was identified.As part of depuy mitek's quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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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