MAUDE Adverse Event Report: ARTHREX, INC. OBTURATOR, PIN GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	OBTURATOR, PIN GUIDE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 0616-000 obturator, pin guide, batch number 202112b, was received for investigation.Visual inspection revealed that the head of the device was fractured.Functional testing was not performed due to the observed damage to the device.Most likely cause: excessive user-applied mechanical forces resulting in fracture of the device head.Refer to the investigation photographs for documentation of findings.Based on the evaluation results, the complaint allegation is confirmed.

• Brand Name: OBTURATOR, PIN GUIDE
• 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: 23744623
• Report Number: 1220246-2025-05477
• Device Sequence Number: 21419954
• Product Code: HSB
• UDI-Device Identifier: 00848665002478
• UDI-Public: (01)00848665002478(11)210730(10)202112B
• 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: OBTURATOR, PIN GUIDE
• Device Catalogue Number: 0616-000
• Device Lot Number: 202112B
• 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: 07/30/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown