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

Model Number	125° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged 1267-100 radiolucent targeting arm lot number: 210923 was received for investigation.Visual evaluation noted wear and tear and the device was slightly discolored where the nail attaches.The most likely cause for this failure can be attributed to wear and tear incurred from repeated use.Functional testing was performed by assembling the 1267-100 radiolucent targeting arm with an 0617-300 lag screw sheath lot number: p12888 and it was found that the 1267-100 radiolucent targeting arm would not hold the lag screw sheath tightly and securely in the insertion hole as intended.It was not noted that the button was sticking.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated use.Refer to investigation photos.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 4/25/2024, it was reported by a sales representative via (b)(4) that a 1267-100 radiolucent targeting arm was unable to keep the lag screw sheath tight inside the jig insertion hole.It was stated that the jig buttons were "sticking" and not holding the outer sheath as it was prior.The case was completed with all standard instrumentation.There were no adverse effects on the patient and no delay in the case.This was discovered during a trochanteric nail for intertroch fx procedure on (b)(6) 2024, with no reported patient harm.

• 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: 19398026
• Report Number: 1220246-2024-03923
• Device Sequence Number: 7800196
• Product Code: HSB
• UDI-Device Identifier: 00848665028652
• UDI-Public: 00848665028652
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/16/2024

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: 210923
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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