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	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 10/31/2023, it was reported by a sales representative via sems-06071680 that an 0312-200 3.2mm pin guide welded into place, and they were unable to remove the pin from the pin guide.This occurred while performing a troch nail procedure when the surgeon advanced the pin, it then cold-welded into place, and they were unable to remove the pin from the pin guide intraoperatively.They were able to complete the lag socket with the lag hole drill bit and advance the lag screw without further incident.There were no patient effects.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Functional testing was not performed on the returned 0312-200 due to the damage to the device.Visual evaluation noted that a pin is stuck into the tip of the device.The most likely cause is attributed to misuse due to interference with the mating instrument.Refer to the investigation photos.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18242743
• Report Number: 1220246-2023-09016
• Device Sequence Number: 6581923
• Product Code: HSB
• UDI-Device Identifier: 00848665010664
• UDI-Public: 00848665010664
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 11/21/2024

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: Ø3.2MM PIN GUIDE, LOCKING
• Device Catalogue Number: 0312-200
• Device Lot Number: 211587
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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