MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RGDLOOP ADJUSTABLE LONG; 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	05/21/2024
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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary: the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (221l998), and no non-conformances related to the reported complaint condition were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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.Device was used for treatment, not diagnosis.Udi: (b)(4).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 submitted accordingly.
Event or Problem Description
It was reported from colombia that during an anterior cruciate ligament reconstruction procedure, it was observed that the rgdloop adjustable long device burst at the time of performing the tension of the graft.Another like device was used to complete the procedure.There were no adverse consequences to the patient nor surgical delay 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 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.Device was used for treatment, not diagnosis.Investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device comes in used condition.The white suture was found broken and frayed.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 (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.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 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.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 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.A manufacturing record evaluation was performed for the finished device lot number (221l998), and no non-conformances related to the reported complaint condition were identified.

• 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 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: 19470322
• Report Number: 1221934-2024-01931
• Device Sequence Number: 19721323
• Product Code: MBI
• UDI-Device Identifier: 10886705024100
• UDI-Public: 10886705024100
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,User Facility,Company Representative
• Initial 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 232448
• Device Lot Number: 221L998
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 03/25/2025
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/12/2024; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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