MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T4, SELF RETAINING,MINI AO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T4, SELF RETAINING,MINI AO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/06/2024 it was reported by a sales representative via e-mail that an ar-18700-09 driver shaft and an ar-18700-29 driver shafts tips broke off.This occurred during a case where the drivers broke off into the ar-1871v-08 screw head in the ar-18714p-12 plate.One of the tips from an ar-18700-29 driver could not be retrieved as it cold welded to the screw.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is attributed to user error of the device due to over-torquing/over-engaging the driver within the screw head.

• Brand Name: DRIVER SHAFT, T4, SELF RETAINING,MINI AO
• 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: 19668804
• Report Number: 1220246-2024-06571
• Device Sequence Number: 16928179
• Product Code: LXH
• UDI-Device Identifier: 00888867313781
• UDI-Public: 00888867313781
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: DRIVER SHAFT, T4, SELF RETAINING,MINI AO
• Device Catalogue Number: AR-18700-09
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown