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

Catalog Number	232448
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
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.E1: the reporter's complete facility address was not provided.H11: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Event or Problem Description
It was reported that during anterior cruciate ligament surgery, when the rigidloop suture was tightened, the suture was broken off.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information was provided.
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 product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the green, white and green/white suture were attached to the pin.However, most of the white suture was broken and frayed.The broken fragment was not returned for evaluation.No other anomalies were noted.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 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 ifu the steps for a proper insertion are provided.The overall complaint was confirmed as the observed condition of the rgdloop adjustable long would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to an 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: 1) the steps for a proper insertion are provided.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.It has been determined that no corrective and/or preventative action is required.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.There was no non-conformance regarding this lot.

• 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; la locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24689692
• Report Number: 1221934-2026-01227
• Device Sequence Number: 9653523
• Product Code: MBI
• UDI-Device Identifier: 10886705024100
• UDI-Public: (01)10886705024100(10)194L228(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 232448
• Device Lot Number: 194L228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2023
• 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
• Patient Sex: Unknown