MAUDE Adverse Event Report: ARTHREX, INC. PARALLEL PIN GUIDE, BULLET NOSE, 3.2MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	PARALLEL PIN GUIDE, BULLET NOSE, 3.2MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/24/2024, it was reported by a sales representative via sems-(b)(4) that an 0322-000 pin guide got stuck around a 3.2 pin.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, 0322-000, serial/batch number (b)(6), was received for investigation.Visual inspection noted that a guide pin was lodged within the device.The guide wire was severely bent.No abnormalities were present when the pin guide holes were assessed.No functional testing was performed for this device due to the damage of the device.The most likely cause for the reported failure can be attributed to use error due to prying/leveraging the guide wire within the guide, leading to the parts cold-welding together.

• Brand Name: PARALLEL PIN GUIDE, BULLET NOSE, 3.2MM
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• 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: 19833932
• Report Number: 1220246-2024-06815
• Device Sequence Number: 7877970
• Product Code: KTW
• UDI-Device Identifier: 00848665001518
• UDI-Public: 00848665001518
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 09/23/2024

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: PARALLEL PIN GUIDE, BULLET NOSE, 3.2MM
• Device Catalogue Number: 0322-000
• Device Lot Number: 220656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown