MAUDE Adverse Event Report: ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	125° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
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 09/03/2024, it was reported by a sales representative via (b)(6) that a 1267-100 radiolucent targeting arm¿s metal piece had broken off of the case.This occurred during use in a case with no patient impact.Additional information has been requested.On 9/27/2024, the sales representative provided the following additional information via email: the metal pin came out during a lag screw removal/replacement procedure.The surgeon expressed that the telescoping lag screw was too long and the lag screw did not lock into the nail from the first surgery that was performed almost three months prior, and the lag screw was backing out.The surgeon attempted to place the jig back onto the troch nail which was located inside the femur from a previous surgery.A 3.2 guidewire was used to guide the jig onto the back of the nail.The jig was rotated several times to try and fully seat onto the nail, but there was some gapping that the surgeon was not satisfied with.The impactor pad was assembled to the jig and the surgeon tried to mallet the jig onto the nail.A nail was pulled to show the surgeon how the slots needed to line up, and again several attempts were made to place the jig.One of the metal pins that hold the silver end of the jig popped out and was stuck in the soft tissue.It was noticed on x-ray and was retrieved by the surgeon under x-ray out of the soft tissue with a pituitary rongeur.Once that piece was retrieved, the surgeon decided to not use the jig and used extensive x-ray and free-handed the removal of the old lag screw and free-handed putting in the new lag screw.Additional information has been requested.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged 1267-100 radiolucent targeting arm lot number: 210918 was received for investigation.Visual evaluation of the returned device noted that a pin was missing near the nail attachment area.Functional testing was not performed as the reported failure was confirmed visually.The most likely cause for the reported failure can be attributed to misuse/user error of the device due to user-applied excessive mechanical forces during impactation.Refer to investigation photos.
Event or Problem Description
On 10/17/2024, the sales representative provided the following information via phone: the additional surgery was delayed by 10 minutes, and no additional anesthesia was administered.The patient has been fine to date.

• Brand Name: 125° 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: 20352445
• Report Number: 1220246-2024-07925
• Device Sequence Number: 8108302
• Product Code: HSB
• UDI-Device Identifier: 00848665028652
• UDI-Public: 00848665028652
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/30/2024

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: 125° RADIOLUCENT TARGETING ARM
• Device Catalogue Number: 1267-100
• Device Lot Number: 220990A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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