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	10/06/2024
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 10/11/2024, it was reported by a sales representative via (b)(4) that an 1268-100 radiolucent targeting arm had the green button on the jig popped off onto the floor during impaction.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged 1268-100 serial/batch number (b)(6) was received for investigation.Functional testing was not performed because the device was received damaged for evaluation.A visual evaluation revealed that the green button was detached from the device, and signs of wear and tear were noted as the black material appeared faded.The most likely reason for the reported failure is wear and tear over repetitive use.

• 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: 20558053
• Report Number: 1220246-2024-08306
• Device Sequence Number: 16934743
• Product Code: HSB
• UDI-Device Identifier: 00848665028645
• UDI-Public: 00848665028645
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/31/2025

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: 00848665028645
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/31/2025
• 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