MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T6, SELF RETAINING, AO
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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
On 01/09/2025 a sales representative reported, via (b)(4), that an ar-18800-03 driver shaft, t6, self-retaining, was no longer viable for inserting the implant and was torqued.The patient was not affected.This was discovered during a procedure with no reported patient harm.Additional information was received on 1/13/2025: this was discovered during an ankle fracture procedure on (b)(6) 2025.An additional driver in the set was used to complete the case.The patient was not affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-18800-03 driver shaft batch number: 1392347 was received for investigation.Visual evaluation of the returned device noted that the drive geometry at the distal tip of the device was twisted.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 over-torqueing/over-engaging the driver with the screw head.

• Brand Name: DRIVER SHAFT, T6, SELF RETAINING, 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: 21313264
• Report Number: 1220246-2025-00199
• Device Sequence Number: 8168948
• Product Code: LXH
• UDI-Device Identifier: 00888867385566
• UDI-Public: (01)00888867385566(11)231201(10)1392347
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/19/2025

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, T6, SELF RETAINING, AO
• Device Catalogue Number: AR-18800-03
• Device Lot Number: 1392347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown