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

Model Number	130° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
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 (b)(6) 2023, it was reported by a sales representative via sems that a 1268-100 radiolucent targeting arm is cracked.This occurred during a trochanteric nail on (b)(6) 2023, the impactor pad cracked the 130° trochanteric nail radiolucent targeting arm.The surgeon successfully pivoted to a 125° nail and matching 125° targeting arm.The patient was not affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged 1268-100 batch number 130082 was received for investigation.The returned devices were visually evaluated, and it was found that the pin close to the connector was sticking out.There is a crack close to the threaded hole and damage in the internal curve of the arm.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17671081
• Report Number: 1220246-2023-07761
• Device Sequence Number: 15034029
• Product Code: HSB
• UDI-Device Identifier: 00848665028645
• UDI-Public: 00848665028645
• 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): 11/06/2024

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: 130082
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/06/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown