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

Model Number 232447

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It was reported by the affiliate in armenia that during an unknown procedure on (b)(6) 2022, it was observed that the rigidloop adjustable cortical implant, standard device broke.According to the report, the device broken when half of the graft was in the canal of femoral bone; and the graft jumped out of the canal.It was unknown how the procedure was completed with a delay of 40 minutes.There were no adverse patient consequences reported.

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 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.

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 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.H10 additional narrative: investigation summary: the product has not been returned to mitek for evaluation, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it appeared that the white suture is broken and frayed, rests of biological matter are visible over the suture.A manufacturing record evaluation was performed for the finished device 9l11006 number, and no non-conformances were identified.According with the visual inspection result, this complaint can be confirmed.An investigation was made with the manufacturer; as a result, the white suture is utilized to assembly onto a graft construction which provides fixation.The green/white suture works as the lead suture for pulling the implant/graft construction with tension, the tension values are associated with this final implant assembly; the strength requirement for the sutures are 250n clinical spec ~1700n.The clinical spec tension is high compared with the expected intraoperative loads of 20-50n.Therefore, based on the work instruction of finish goods, the tension is measured only on the green/white suture during the manufacturing process.Since the white suture is broken and considering the damaged condition, a pull test is not required.Regarding the white suture, an inspection is performed during the manufacturing process to verify its size and condition, this information corresponds with the process control, and its record guarantees the white suture inspection.Since the suture breakage couldn't be originated during manufacturing process, the breakage can be attributed to procedure variables such as excessive counter tension or other instrument that pulls the white suture which creates a stress point on the suture, leading to a breakage.As per instructions for use the steps for a proper insertion are provided.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.

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 product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.The complaint device was received and evaluated.Upon visual inspection, it was noted that the button does not show structural anomalies, the white suture was broken and frayed, there was biological matter impregnated in the suture.A manufacturing record evaluation was performed for the finished device 9l11006 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 result, this complaint can be confirmed.An investigation was made with the manufacturer; as a result, the white suture is utilized to assembly onto a graft construction which provides fixation.The green/white suture works as the lead suture for pulling the implant/graft construction with tension, the tension values are associated with this final implant assembly; the strength requirement for the sutures are 250n clinical spec ~1700n.The clinical spec tension is high compared with the expected intraoperative loads of 20-50n.Therefore, based on the work instruction of finish goods 103050528, the tension is measured only on the green/white suture (111455) during the manufacturing process.Since the white suture is broken and considering the damaged condition, a pull test is not required.Regarding the white suture, an inspection is performed during the manufacturing process to verify its size and condition, this information corresponds with the process control, and its record guarantees the white suture inspection.Since the suture breakage couldn't be originated during manufacturing process, the breakage can be attributed to procedure variables such as excessive counter tension or other instrument that pulls the white suture which creates a stress point on the suture, leading to a breakage.As per ifu: the steps for a proper insertion are provided.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.

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: d9, h3, h6: 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.

• 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: 16178938
• MDR Text Key: 308922608
• Report Number: 1221934-2023-00371
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705024094
• UDI-Public: 10886705024094
• Combination Product (y/n): N
• Reporter Country Code: AM
• PMA/PMN Number: K140324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 232447
• Device Catalogue Number: 232447
• Device Lot Number: 9L11006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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