MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 5.5HLX ADV BR ANC-DYNA STR/BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.A manufacturing record evaluation was performed for the finished device 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.
Event or Problem Description
Event description: re-tears or new tears [post-operative].Operative side: right.Was the fms vue ii system used for this procedure?: yes, was the vapr system used for this procedure?: yes, was the speedtrap graft preparation system used for this procedure?: no.If the start date is equal to the date of procedure, when did the event occur?: blank.Severity: moderate.Did this event result in a re-operation/revision? if yes, complete the re-operation/revision form.: yes, has implant caused or contributed to death or serious injury to the patient?: no.

• Brand Name: 5.5HLX ADV BR ANC-DYNA STR/BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 22575309
• Report Number: 1221934-2025-02700
• Device Sequence Number: 9637751
• Product Code: MAI
• UDI-Device Identifier: 10886705029464
• UDI-Public: (01)10886705029464(10)9L11388(17)250228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: 02/28/2025
• Device Catalogue Number: 222004
• Device Lot Number: 9L11388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female