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

Model Number	130° RADIOLUCENT TARGETING ARM
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
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 03/06/2025, it was reported by a sales representative via (b)(4) that an 1268-100 130° radiolucent targeting arm would not target the distal static cortical screw hole.The case was completed.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b3, b5, h3, h6.
Event or Problem Description
Additional information was received on 03/12/2025: this occurred at the end of the case during a troch fx procedure on (b)(6) 2025.They used another 1268-100 130° radiolucent targeting arm and a different hole to complete the case.They used a dynamic hole, not a static one, to complete the case.There was no case delay.There were no adverse effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged 1268-100 130° radiolucent targeting arm batch number: 212054 was received for investigation.Visual evaluation of the returned device noted superficial wear and tear to the device.Functional testing was performed by assembling the returned device with known good mating parts and it was found that the returned device was able to target and align with the distal static cortical screw hole as intended.No problem found.Refer to investigation photos.

• 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: 21663771
• Report Number: 1220246-2025-01104
• Device Sequence Number: 7574308
• Product Code: HSB
• UDI-Device Identifier: 00848665028645
• UDI-Public: (01)00848665028645(11)210929(10)212054
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/02/2025

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: 212054
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided; 06/09/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/01/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown