MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RIGIDLOOP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	232448
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the complaint device was not returned to depuy synthes, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (8l67308), and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.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.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Post market complication received for re-tears or new tears (left knee displaced bucket handle medial meniscus tear).Date of event: (b)(6) 2025.Date of implant: (b)(6) 2023 (left acl tear, medial meniscus tear, lateral meniscus tear).Date of reoperation/revision: (b)(6) 2025.Device location: right.Treatment/impact: re-operation with no implant removed/implanted.Depuy synthes products used: rgdloop adjustable long.Catalog number: 232448.Lot number: 8l67308.Depuy synthes products used: truespan 12 degree peek.Catalog number: 228151.Lot number: 9l71051.Depuy synthes products used: intrafix advance 10x23 screw & large 23mm sheath.Catalog number: 254803.Lot number: 9l62950.Depuy synthes products used: 5.5mm healix advance sp biocomposite anchor.Catalog number:222424.Lot number: 116l683.Report 1 of 4 for (b)(4).

• Brand Name: RIGIDLOOP
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25301074
• Report Number: 1221934-2026-02208
• Device Sequence Number: 13084891
• Product Code: MBI
• UDI-Device Identifier: 10886705024100
• UDI-Public: (01)10886705024100(10)8L67308(17)241031
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 232448
• Device Lot Number: 8L67308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 81 KG