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 04/12/2023

Event Type  Injury  

Event Description

It was reported by the healthcare professional in switzerland that during an unknown procedure in the morning of (b)(6) 2023, a rigidloop adjustable cortical implant, standard device was used.According to the report, an x-ray was performed after the surgery in the afternoon on the same day when it was observed that the device broke.It was reported that the next day, a revision surgery was performed to remove the broken implant and remix the new ligament.The status of the patient was good; and that there was currently no negative impact.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.Udi: (b)(4).H4: the device manufacture date is currently unavailable.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.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.

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.Investigation summary: the device was received to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it could be observed the white and green/white suture are frayed and broken.The green suture was not received along with the device.No anomalies were found in the cortical implant.This complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 9l96465, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.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 (b)(4), the tension is measured only on the green/white suture (111455) during the manufacturing process.Since the white suture was broken and the green/white suture size is less than 5 inches, the pull test could not be performed.The measurement value and the condition of the sutures; this information correspond to a process control, and it is the document to use to guarantee the inspection of the suture, due to this broken suture can¿t have happened during manufacturing process.It is possibly a result of too much tension on the adjusting suture when attempting to keep the adjustable cortical implant button in place have resulted in fraying; also, could be related to the handling of the device, when inserting through the bone tunnel, the white suture could have rubbed with the bone internal walls.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.

• 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: 16889410
• MDR Text Key: 314770924
• Report Number: 1221934-2023-01959
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705024094
• UDI-Public: 10886705024094
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K140324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 9L96465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/12/2023; 06/03/2023
• Supplement Dates FDA Received: 05/16/2023; 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 16 YR