MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T10 HEXALOBE, CANNULATED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T10 HEXALOBE, CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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 (b)(6) 2023, it was reported by a sales representative via sems that an ar-8737-16 and an ar-8737-25 , 2.4 and 3.0 cannulated drivers broke during a case due to wear and tear.Patient was not affected.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual inspection, it was noted that the drive geometry at the distal tip of the returned ar-8737-16 had both twisted and broken.No fragments were returned for inspection.Also, it was noted that the paint groove of both colors is coming off.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Functional testing was not performed due to the damage to the device.

• Brand Name: DRIVER SHAFT, T10 HEXALOBE, CANNULATED
• 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: 17112354
• Report Number: 1220246-2023-06906
• Device Sequence Number: 11296999
• Product Code: LXH
• UDI-Device Identifier: 00888867046115
• UDI-Public: 00888867046115
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/30/2024

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, T10 HEXALOBE, CANNULATED
• Device Catalogue Number: AR-8737-16
• Device Lot Number: 6791145
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 10/30/2024
• 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