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

Model Number	DRIVER SHAFT, T6, NON-RETAINING, AO
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 3/20/2024, it was reported by an arthrex employee via sems (b)(4) that an ar-18800-04 driver shaft (from set ar-18800fs) threads were all twisted after completing the case and inspecting the tray.This was discovered after use on (b)(6) 2024, with no reported patient harm.
Event or Problem Description
Additional information was received on 3/25/2024: this was after a metatarsal fx procedure.
Additional Manufacturer Narrative
Additional information: d9, b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the drive geometry at the distal tip of the driver shaft, t6, ao had twisted.Functional testing was not performed due to the damage to the device.The most likely cause is attributed to user error due to over-torquing/over-engaging the driver within the screw head.Per dfu-0023-12 rev 0 cautions- to avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.

• Brand Name: DRIVER SHAFT, T6, NON-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: 19111880
• Report Number: 1220246-2024-02023
• Device Sequence Number: 7099819
• Product Code: LXH
• UDI-Device Identifier: 00888867385573
• UDI-Public: 00888867385573
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2024

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: DRIVER SHAFT, T6, NON-RETAINING, AO
• Device Catalogue Number: AR-18800-04
• Device Lot Number: 1292325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 07/23/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/29/2024; 08/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown