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

Model Number	130° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/31/2025, it was reported by a sales representative via (b)(4) that an 1268-100 targeting arm is misaligned.Per facility: "130 degree trochanteric nail jig that is misaligning with the static distal interlock hole in the short trochanteric nail.Different outer sheaths have been used and we¿ve had same result.3 of the last 4 cases using this jig have caused surgeon to have an extremely difficult time getting drill bit through the static short nail hole.When i was able to evaluate the jig after the case today, it appears that the 1268-100 jig has slightly more play within the black jig hole than the 125 jig does.My best guess is the tolerance might be slightly different and causing the miss.There has been no patient injury.And he can eventually get the drill bit to go through the nail, and insert the screw with no issue.However, this is an understandable frustration for the surgeon and we are willing to do anything to correct it.".This occurred during use in a case with no patient effect.Case was able to be completed using the jig.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged,1268-100 radiolucent targeting arm, lot number: 160480, was received for investigation.Visual evaluation noted wear and tear and the device was slightly discolored where the nail attaches.Functional testing was performed by assembling the targeting arm with known good trochanteric nail system and the device functioned as intended.No problem found, complaint allegation is not confirmed.

• 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: 21395314
• Report Number: 1220246-2025-00512
• Device Sequence Number: 15546079
• Product Code: HSB
• UDI-Device Identifier: 00848665028645
• UDI-Public: (01)00848665028645(10)160480
• 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
• Report Date (Section B): 04/07/2025

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: 160480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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