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

Model Number	DRIVER SHAFT, T-15, LONG
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
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 11/10/2023, it was reported by a sales representative via (b)(4) that an ar-9165cdg baseplate impactor plastic tip is broken.This was discovered after use in a case with no patient harm."broken items were discovered in cleanup, did not affect the outcome of the case, and did not negatively impact the patient.".
Additional Manufacturer Narrative
Complaint is confirmed.Functional testing was not performed due to the damage to the device.Visual evaluation noted that the driver shaft tip is twisted/bent.It was not indicated if a torque-indicating adapter had been used with the device.The most likely cause is attributed to misuse due to use error of over-torquing/over-engaging the driver with the screw head.

• Brand Name: DRIVER SHAFT, T-15, LONG
• 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: emily shafer ; 8009337001
• MDR Report Key: 18287198
• Report Number: 1220246-2023-09281
• Device Sequence Number: 6847261
• Product Code: LXH
• UDI-Device Identifier: 00888867225176
• UDI-Public: 00888867225176
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/24/2024

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, T-15, LONG
• Device Catalogue Number: AR-9545-T15-03
• Device Lot Number: 8002109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown