MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 232447

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

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).Initial reporter occupation: 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.

Event Description

This is report 1 of 2 for (b)(4).It was reported by the affiliate in japan that during a two-route anterior cruciate ligament reconstruction on (b)(6) 2022, it was observed that the rigidloop adjustable cortical implant, standard device loose when an x-ray was checked immediately after the wound was closed.According to the report, the x-ray confirmed that the button was standing on the lateral cortex of the femur and that the adjustable suture was loose (the patient was being continued anesthesia).Immediately after that, the affected site was incised again, and the button on the cortex was checked directly.As a result, the suture was loosened, and the device in the pl tendon site was removed.It was reported that while a tibial fixation device was also removed once and the graft was being re-prepared, the surgeon found some loosening in the device for the am tendon when seen arthroscopically.It was reported that while re-tightening the two adjustable sutures on the cortex, the two adjustable sutures got collapsed, too.Therefore, the surgeon removed a tibial fixation device on the am tendon site and re-prepared the graft.The surgery was completed successfully with approximately 120 minutes delay.The status of the patient was unknown.No additional information was provided.

Manufacturer Narrative

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.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the sutures were damage, it was frayed on the distal part.It is not possible to see the condition of the cortical implant.This complaint can be confirmed.The photo does not provide enough evidence to determine root cause.The physical analysis can provide the evidence to discern a root cause.Based on the information requested, it is not available to know if the surgeon confirm the button was properly seated and tensioned prior to initial closure; the root cause can be related to the button not properly seated and the damage in the suture could be attributed when re-tightening too much tension on the adjusting suture when attempting to keep the adjustable cortical implant button in place have resulted in fraying causing it to eventually damage sutures.As per ifu, follow the instructions, it is necessary to confirm button deployment on the cortex and apply counter tension by pulling on graft distally to ensure button remains on the cortex (keep the button oriented across the superior aspect of the tunnel); and lock the knot.Firmly pull down on graft and cycle the knee.A manufacturing record evaluation was performed for the finished device lot number: 9l40675, and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15815977
• MDR Text Key: 303833206
• Report Number: 1221934-2022-03617
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705024094
• UDI-Public: 10886705024094
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 232447
• Device Catalogue Number: 232447
• Device Lot Number: 9L40675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention