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 Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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 03/03/2025, a sales representative reported via (b)(4) that a (qty.2) of an ar-9545-t15-01 driver shaft and an ar-9545-t15-03 driver shaft was twisted and bent over time and unable to be used as intended.The case was completed without adverse effects on the patient.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9545-t15-03, serial/batch number (b)(6) was received for investigation.Functional testing was not performed because of the damage to the device.Visual evaluation noted that the hex head was twisted, and the laser marks were faded.The most likely cause of the reported failure is wear and tear.Device manufacturing date: 22-may-2018.

• 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: jared engle ; 8009337001
• MDR Report Key: 21632502
• Report Number: 1220246-2025-00999
• Device Sequence Number: 9246139
• Product Code: LXH
• UDI-Device Identifier: 00888867225176
• UDI-Public: (01)00888867225176(11)180522(10)8001820
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/14/2025

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, LONG
• Device Catalogue Number: AR-9545-T15-03
• Device Lot Number: 8001820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2018
• 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