MAUDE Adverse Event Report: ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	130° RADIOLUCENT TARGETING ARM
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/26/2025, a facility representative reported via (b)(4) that a cold-welded jig of an 0826-000 impactor pad and 1268-100 130-degree targeting arm broke outside of the patient during a troch nail procedure.No patient was affected.The procedure was completed as normal, and the impactor was taken off at the end.Additional information received on 9/8/2025 from sales rep: it was reported that the break occurred outside of the patient.No fragments were produced.This occurred during a troch nail procedure and was completed as normal as the impactor was just taken off at the end.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged 1268-100, batch number 210929, was received for evaluation.Visual evaluation: the inspection revealed that the threaded connector from batch 1268-100 (lot 210929) was cold-welded to part 0826-000, batch 211082.A hole was left where the connector had been positioned.Functional testing: attempted functional testing could not be completed due to the cold-welded threads between part 1268-100 (batch 210929) and part 0826-000 (batch 211082).The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.The device was manufactured in 2021.

• Brand Name: 130° RADIOLUCENT TARGETING ARM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23062698
• Report Number: 1220246-2025-03877
• Device Sequence Number: 9850014
• Product Code: HSB
• UDI-Device Identifier: 00848665028645
• UDI-Public: (01)00848665028645(11)210903(10)210929
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 130° RADIOLUCENT TARGETING ARM
• Device Catalogue Number: 1268-100
• Device Lot Number: 210929
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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