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 complaint is confirmed.One unpackaged 0494-000 serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to that the device was broken.Visual evaluation found that the device tip was broken off.The cause remains undetermined.
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.

• 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: 16815469
• Report Number: 1220246-2023-06593
• Device Sequence Number: 17563489
• 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
• Report Date (Section B): 04/26/2023

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
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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