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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
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 11/18/2025, it was reported by a facility representative via (b)(4) that an 0312-200 pin guide was inserted into the lag screw guide pin sleeve.When advancing and redirecting for proper placement, the guide pin welded itself to the guide pin sleeve.It could not be removed.Another device was used to complete the case with no patient harm.Also, the cap on an 0616-000 obturator had fallen off or became unstuck from the obturator itself.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged 0312-200 ø3.2 mm pin guide, locking, batch number 190849, was received for investigation.Visual inspection revealed deformation and surface damage at the distal tip, consistent with mechanical binding or galling likely occurring during insertion into the guide pin sleeve.This damage supports the reported inability to remove the pin following advancement and redirection.Functional testing was not performed due to the observed damage to the device.The most likely cause of the reported failure can be attributed to a use-related mechanical interaction involving increased friction during the advancement and redirection of the guide pin within the guide pin sleeve, which resulted in galling (cold welding) between metallic components, causing the pin to become seized.Refer to the investigation photographs for documentation of findings.Based on the evaluation results, the complaint allegation is confirmed.

• 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: 23743605
• Report Number: 1220246-2025-05475
• Device Sequence Number: 8413213
• Product Code: HSB
• UDI-Device Identifier: 00848665010664
• UDI-Public: (01)00848665010664(11)220328(10)190849
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 190849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown