MAUDE Adverse Event Report: ARTHREX, INC. DRILL TIP GUIDE PIN, 2.4MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRILL TIP GUIDE PIN, 2.4MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
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
It was reported that during an acl surgery the drill cold welded with the cannulation and the wire was stuck.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1250l drill tip guide pin, 2.4 mm x 310 mm batch unk was received for investigation.The device arrived stuck inside of ar-1778r-24 retroconstruction constant femoral guide graduated drill sleeve, i.D.2.4 mm batch 1068642439 for investigation.Visual evaluation found that the device was stuck inside the ar-1778r-24, scratch lines around shaft at the distal end.Damaged like nicks were also noted on the threads.Further evaluation noted that the shaft was bent.Functional testing was not performed due to the device was received stuck inside the ar-1778r-24 retroconstruction constant femoral guide graduated drill sleeve, i.D.2.4 mm batch 1068642439.Due to the damaged observed on the ar-1250l drill tip guide pin, 2.4 mm x 310 mm.The most likely cause of the reported and observed failure is user error, specifically applying excessive force bending the drill due to a possible misaligning the insertion.

• Brand Name: DRILL TIP GUIDE PIN, 2.4MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21343828
• Report Number: 1220246-2025-00326
• Device Sequence Number: 7836008
• Product Code: LXH
• UDI-Device Identifier: 00888867087958
• UDI-Public: 00888867087958
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: DRILL TIP GUIDE PIN, 2.4MM
• Device Catalogue Number: AR-1250L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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