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

Model Number	130° RADIOLUCENT TARGETING ARM
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
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 10/14/2025, it was reported by a sales representative via email that the flipcutter iii from an ar-1288rtib-fc3 tightrope ii rt with fibertape ib, flipcutter iii, and fiberstick implant system broke and was unable to be used.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 10/20/2025: during the procedure, the flipcutter broke while retro drilling inside the patient.Fortunately, all fragments were successfully retrieved without complication.To complete the case, an individual ar-1240ff flipcutter iii was used.The incident did not result in any surgical delay, and no additional anesthesia was required.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the information provided, including the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.The inaccurate screw trajectory and subsequent cross-threading appear to have resulted from misalignment during insertion, possibly due to improper targeting arm positioning or improper implant positioning that led to screw misalignment.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 23356330
• Report Number: 1220246-2025-04748
• Device Sequence Number: 21104930
• Product Code: HSB
• UDI-Device Identifier: 00848665028645
• UDI-Public: 00848665028645
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• 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,Followup
• Report Date (Section B): 03/20/2026

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: 130° RADIOLUCENT TARGETING ARM
• Device Catalogue Number: 1268-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 03/20/2026
• 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