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 Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the distal drive geometry 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 of the device due to over-torquing/over-engaging the driver within the screw head.
Event or Problem Description
08/01/2024, it was reported by a sales representative via (b)(4) that an ar-18800-03 driver shaft and an ar-18800-04 driver shafts tips snapped in the locking screws.This occurred during a case with no harm to the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the distal drive geometry 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 of the device due to over-torquing/over-engaging the driver within the screw head.
Event or Problem Description
On 08/05/2024 additional information was provided by the sales representative via email who stated that the event took place on 07/31/2024.One head of one of the t6 drivers was completely removed from the screw head.The other t6 driver head seemed to have a left a small piece behind, lodged and fused with the screw head to the point the surgeon was unable to retrieve all of it.He decided best to leave it in place.There was one photo taken and is attached.The procedure was completed with an additional non-retaining t6 driver to implant the final two screws.No harm to the patient was recorded.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.

• 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: 20074989
• Report Number: 1220246-2024-07277
• Device Sequence Number: 3034969
• Product Code: LXH
• UDI-Device Identifier: 00888867385566
• UDI-Public: 00888867385566
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2024

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, 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: 08/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 08/26/2024; 08/05/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/12/2024; 12/18/2024
• 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
• 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