MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX DRIVER SOLID, CMP FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1.5MM HEX DRIVER SOLID, CMP FT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/28/2022
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) 2022, it was reported by a sales representative via phone that a ar-8725-50h micro compression ft¿ screw, a ar-8737-45 driver shaft, and a ar-8737-37 driver shaft broke.This occurred during a metacarpal shaft fracture on (b)(6) 2022 when the ar-8725-50h screw broke half way during implantation into the metacarpal.Once the screw was extracted and the other screw was being implanted the ar-8737-45, and ar-8737-37 driver shafts also broke.The case was completed using a metal cutting burr to cut the remaining end of the screw off and just burr it down till it was down to the articular surface.All fragments of the broken devices were retrieved.There was no patient effect reported.

• Brand Name: 1.5MM HEX DRIVER SOLID, CMP FT
• 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: 15803919
• Report Number: 1220246-2022-05756
• Device Sequence Number: 20239650
• Product Code: LXH
• UDI-Device Identifier: 00888867197787
• UDI-Public: 00888867197787
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 11/16/2022

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: 1.5MM HEX DRIVER SOLID, CMP FT
• Device Catalogue Number: AR-8737-45
• Device Lot Number: 011946
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/16/2022
• Date Device Manufactured: 11/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown