MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRFX ADV - LG 30MM INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	254834
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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.E1: the reporter¿s complete facility address was not provided.
Event or Problem Description
It was reported that during an unknown surgery, an intrfx adv - lg 30mm inserter's cannulation clogged.There was no delay in the procedure reported.There were no adverse patient consequences reported.All available information has been disclosed.The exact date of the event was unknown.However, it was reported that the event occurred in 2026.
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.H11 additional narrative: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found scratch marks along the overall surface indicating heavy use in the field.No obstruction of the canula was found.No other anomalies could be observed.A functional testing was performed by passing a pin gage through the canula.The pin gage passed through the whole canula as expected.The overall complaint was not confirmed as the observed condition of the intrfx adv - lg 30mm inserter would have not contributed to the complained issue.Based on the investigation findings, the potential cause cannot be established since no defect was found.As per ifu complex devices, such as those with tubes, hinges, retractable features, mated surfaces, and textured surface finishes, require special attention during cleaning.Manual pre-cleaning of such device features is required before automated cleaning processing.Prior to sterilization, instruments should be thoroughly cleaned by either automated or manual means described below.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 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 a manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.

• Brand Name: INTRFX ADV - LG 30MM INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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 ; 9083863534
• MDR Report Key: 24294794
• Report Number: 1221934-2026-00521
• Device Sequence Number: 15811497
• Product Code: LXH
• UDI-Device Identifier: 10886705026319
• UDI-Public: (01)10886705026319(10)1604001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 254834
• Device Lot Number: 1604001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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