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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 02/15/2024, it was reported by a sales representative via (b)(4) that an ar-18800-03 driver shaft and ar-18800-04 driver shaft broke.This occurred during use in a case with no patient effect.Additional information requested.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged ar-18800-04 serial/batch number (b)(6) was received for investigation.Visual evaluation found that the hex tip was twisted.The most likely cause is attributed to misuse due to use error of over-torquing/over-engaging the driver with the screw head.The complaint allegation noted that the shaft was broken.After measuring the driver, the complaint could not be confirmed.The length of the driver shaft was measured with caliper id: (b)(4) and had an expected length of 3.600 ±.020, passing with a tolerance of 3.599.

• 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: 18827564
• Report Number: 1220246-2024-01266
• Device Sequence Number: 12709404
• Product Code: LXH
• UDI-Device Identifier: 00888867385573
• UDI-Public: 00888867385573
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/19/2024

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: 1392241
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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