MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORTHOCORDVIOLET W/MO-6 NDLS PK/12; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	223102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent repair surgery of the shoulder and clavicular joint dislocation at the end of (b)(6) 2025.During the surgery, the surgeon used three rgdloop adjustable stnd devices for soft tissue fixation.During the procedure, it was reported that the surgeon cut off the white suture of the device and used two orthocord violet w/mo-6 ndls devices instead to pass the titanium plate for fixation.It was reported that postoperative x-ray was unremarkable.Subsequently, the patient felt shoulder discomfort and went to the hospital for treatment (the specific process, occurrence date, examination results and diagnosis were unknown).On (b)(6) 2025, a second surgery was performed for refixation.During the surgery, it was found that the sutures of the orthocord violet w/mo-6 ndls devices were broken.It was reported that currently, the patient's condition is stable and no further adverse event reports have been received.No additional information was provided.This is report 5 of 5 for (b)(4).
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.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.
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.H11 additional narrative: investigation summary = > the complaint device was implanted in the patient, therefore not returned to j&j medtech orthopaedics and unavailable for a physical evaluation.Manufacturing record evaluation was performed for the finished device lot number, 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 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: ORTHOCORDVIOLET W/MO-6 NDLS PK/12
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 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: 22460911
• Report Number: 1221934-2025-02494
• Device Sequence Number: 8633006
• Product Code: NEW
• UDI-Device Identifier: 10886705008735
• UDI-Public: (01)10886705008735(10)1060DK(17)271231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040004
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 223102
• Device Lot Number: 1060DK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown