MAUDE Adverse Event Report: ARTHREX, INC. Ø3.2MM PIN GUIDE, LOCKING; INTRAMED FIXATN ROD AND ACCESS

Model Number	Ø3.2MM PIN GUIDE, LOCKING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/06/2025, it was reported by a sales representative via (b)(4) that an 0312-200 locking pin guide black connection broke and would not click into the outer sheath due to wear and tear.This was discovered during the case.The sleeve was pushed down on the outer sleeve to get accurate measurements, and the case was completed with no patient harm.
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.Complaint allegation is confirmed.Visual inspection of the ø3.2mm pin guide, locking, noted that the black clip was broken off.Functional testing was not performed due to the damaged to the device.The most likely cause of the reported failure can be attributed to wear and tear due to repeated use of the device in the field.

• Brand Name: Ø3.2MM PIN GUIDE, LOCKING
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 23656880
• Report Number: 1220246-2025-05210
• Device Sequence Number: 4770006
• Product Code: HSB
• UDI-Device Identifier: 00848665010664
• UDI-Public: (01)00848665010664(11)221213(10)220985
• 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): 02/10/2026

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: Ø3.2MM PIN GUIDE, LOCKING
• Device Catalogue Number: 0312-200
• Device Lot Number: 220985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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