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

Model Number	130° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
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 07/16/2024, it was reported by a sales representative via sems-(b)(4) that a 1268-100 targeting arm was misaligned and repeatedly missed the lag screw.And a 0312-200 pin guide was getting stuck in the sleeve spring.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged 1268-100 targeting arm lot number: 210295 was received for investigation.Visual evaluation noted no problems with the device.Functional testing was performed by assembling the 1268-100 targeting arm with a 1059-390 trochanteric nail lot number: 211400 and a lag screw assembly consisting of a 1099-100 telescoping lag screw lot number: 220943.A 5031-000 locking tool lot number: 212675-090, a 5032-000 compression sleeve lot number: 212018, a 5030-000 lag screw inserter lot number: 212668 and a 5033-100 capturing rod lot number: 220097.It was noted that when the lag screw assembly was placed through the 1268-100 targeting arm, the lag screw was able to align with the 1059-390 trochanteric nail as intended.Further functional testing of the buttons of the device revealed no problem with the device.No problem found.

• 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: 19961205
• Report Number: 1220246-2024-07136
• Device Sequence Number: 17935634
• 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): 09/27/2024

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: 210295
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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