MAUDE Adverse Event Report: Medos International SÃ rl INTRAFIX; Fastener, fixation, biodegradable, soft tissue

Catalog Number	254802
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament reconstruction procedure, it was discovered that the sheath on the intrafx advbr scw9x23 w/lgshth device broke off.All the broken parts were removed.It was not reported if there were any delays to the surgical procedure.It was reported that a spare device was used to complete the surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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.Investigation summary: the product was not returned to depuy synthes, however a photo was provided for evaluation.Visual inspection of the returned photo found that the device is shown in used condition.Biological matter can be observed on the device.The sheath was found broken.The overall complaint was confirmed as the observed condition of the intrafx advbr scw9x23 w/lgshth would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause is traced to the malleting action of the screw and levering the inserter can contribute to sheath breakage; as per instructions for use (ifu), the instructions for proper insertion are provided.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 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.Device history review: there was no non-conformance regarding this lot.

• Brand Name: INTRAFIX
• 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: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50474503
• Report Number: 1221934-2026-03836
• Device Sequence Number: 10136109
• Product Code: MAI
• UDI-Device Identifier: 10886705026746
• UDI-Public: (01)10886705026746(10)298L837(17)270430
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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 Catalogue Number: 254802
• Device Lot Number: 298L837
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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