MAUDE Adverse Event Report: ARTHREX, INC. BALL HEX DRIVER, CANNULATED; ORTHOPEDIC, MANUAL SURGICAL INSTRUMENT

Model Number	BALL HEX DRIVER, CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
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 03/27/2023, it was reported by a sales representative via sems that a screw cross threaded and stripped the threads on both an 1239-100 insertion guide, and a 1255-300 tibial insertion guide.In attempts to retrieve it (2) 0494-000 ball hex driver broke.This occurred during a case, with no patient effect reported.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) for the reported failure can be a user error due to excessive force applied to the device.

• Brand Name: BALL HEX DRIVER, CANNULATED
• Common Device Name: ORTHOPEDIC, MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16815461
• Report Number: 1220246-2023-06592
• Device Sequence Number: 5682756
• Product Code: LXH
• UDI-Device Identifier: 00848665013467
• UDI-Public: 00848665013467
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: BALL HEX DRIVER, CANNULATED
• Device Catalogue Number: 0494-000
• Device Lot Number: 212429
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown