MAUDE Adverse Event Report: ARTHREX, INC. 2.8MM GUIDE PIN; SMOOTH FIXATION PIN

Model Number	2.8MM GUIDE PIN
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill wire is worn and runs out of round.It was noticed after the surgery.There was no harm for patient, operator or third party.There was no case involvement reported.No further information received.
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.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the surface around the 2.8 mm guide pin was chipped and scratched.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: 2.8MM GUIDE PIN
• Common Device Name: SMOOTH FIXATION PIN
• 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: 19343020
• Report Number: 1220246-2024-03453
• Device Sequence Number: 7143528
• Product Code: LXH
• UDI-Device Identifier: 00888867298279
• UDI-Public: 00888867298279
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 2.8MM GUIDE PIN
• Device Catalogue Number: AR-9616
• Device Lot Number: 45552235
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown