MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, SHORT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T-15, SHORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
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, t-15, short had twisted.Functional testing was not performed due to the damage to the device.It was not indicated if a torque-indicating adapter had been used with the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly torquing/engaging the driver within the screw head and extended use in the field.Manufacturing date 2019.
Event or Problem Description
On 08/07/2024, it was reported by a sales representative via (b)(4) that an ar-9545-t15-01 driver shafts tip chipped off due to wear and tear.This occurred during a case where there was a backup tray on standby that was used to complete the case.
Additional Manufacturer Narrative
Correction: b4.Additional information: b5, g3, h6.
Event or Problem Description
On 08/09/2024 additional information was provided by a sales representative via email who stated that the event date was (b)(6) 2024.The type of procedure performed was an rtsa.All fragments were retrieved from the patient.A backup tray with the same instruments were used to complete the procedure.14892.

• Brand Name: DRIVER SHAFT, T-15, SHORT
• 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: 20138339
• Report Number: 1220246-2024-07359
• Device Sequence Number: 3151832
• Product Code: LXH
• UDI-Device Identifier: 00888867225183
• UDI-Public: 00888867225183
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/17/2025

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, T-15, SHORT
• Device Catalogue Number: AR-9545-T15-01
• Device Lot Number: 8001943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 01/17/2025
• 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