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

Catalog Number	232448
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional 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.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during an unspecified surgical procedure the 4rgdloop adjustable long device had a fault with the input detected.The fault was due to a factory error and therefore the procedure could not be performed with that input.It was unknown if a like device was used to complete the procedure.It was unknown if there was a delay in the procedure reported.There was patient involvement.There were no adverse patient consequences reported.No additional information was provided.
Additional 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.H11 additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that it is in used condition.White and white-green suture were found to be broken and frayed.Green suture was not returned.Button does not show structural anomalies.The overall complaint was confirmed as the observed condition of the rgdloop adjustable long would have contributed to the complained device issue.¿ the white suture is used to assembly into a graft construction with provides fixation.The green / white suture is the lead suture due to it is used to pull the implant/ graft construction with tension, the tension values are associated with this final implant assembly.Based on the investigation findings and due to the device was returned in used condition, the out of the box failure cannot be substantiated however, the potential root cause 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.Therefore it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.

• Brand Name: RGDLOOP ADJUSTABLE LONG
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21337649
• Report Number: 1221934-2025-00504
• Device Sequence Number: 3759062
• Product Code: MBI
• UDI-Device Identifier: 10886705024100
• UDI-Public: (01)10886705024100(10)9L92628(17)250930
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 09/30/2025
• Device Catalogue Number: 232448
• Device Lot Number: 9L92628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2022
• 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