MAUDE Adverse Event Report: Arthrex, Inc. 22cm EXTENSION, TARGETING GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	22cm EXTENSION, TARGETING GUIDE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 2-sep-2026, it was reported by a sales representative via sems-07477298 that a 1283-000 extension targeting guide was damaged.It was reported that the surgeon lined up assembly to test trajectory of proximal screw through the jig prior to insertion which was successful.However, the nail assembly was tight, no soft tissue binds and the targeted proximal screw missed the nail.This was discovered during a distal femur fracture addressed with a short retrograde femoral nail procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 22cm EXTENSION, TARGETING GUIDE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50802253
• Report Number: 1220246-2026-04774
• Device Sequence Number: 13409237
• Product Code: HSB
• UDI-Device Identifier: 00848665017069
• UDI-Public: 00848665017069
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Model Number: 22cm EXTENSION, TARGETING GUIDE
• Device Catalogue Number: 1283-000
• Device Lot Number: 180556
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown