MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT FOR DX SWIVELOCK, 4.75 MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISPOSABLE KIT FOR DX SWIVELOCK, 4.75 MM
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Component Misassembled (4004)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 31st october 2023, it was reported by a sales rep.Via email that an ar-8980ds, disposable kit for dx swivelock®, 4.75mm, was faulty as it had a completely squared tip instead of a pointy tip, was not drilling through bone and was causing heat buildup and some burning of bone edges through friction.This was discovered during use in a achilles reconstruction on 27th october 2023.The case was completed successfully with another drill kit with the same lot number.
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
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure can be attributed to user error specifically mishandling the device.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: DISPOSABLE KIT FOR DX SWIVELOCK, 4.75 MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18192005
• Report Number: 1220246-2023-08877
• Device Sequence Number: 7246937
• Product Code: LXH
• UDI-Device Identifier: 00888867319851
• UDI-Public: 00888867319851
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DISPOSABLE KIT FOR DX SWIVELOCK, 4.75 MM
• Device Catalogue Number: AR-8980DS
• Device Lot Number: 15010467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown