MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	DRIVER, T10 HEXALOBE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/18/2022, it was reported by medwatch via email that an ar-8944dh driver tip broke in the head of the screw.Broken piece was unable to be retrieved.This was discovered during an unspecified procedure on (b)(6) 2022.
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.

• Brand Name: DRIVER, T10 HEXALOBE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 15743272
• Report Number: 1220246-2022-05707
• Device Sequence Number: 14683374
• Product Code: MDM
• UDI-Device Identifier: 00888867053045
• UDI-Public: 00888867053045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

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: DRIVER, T10 HEXALOBE
• Device Catalogue Number: AR-8944DH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown