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

Model Number	AR-8944DH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of arthrex screw driver tip broke of in head of screw.Unable to retrieve.

• Brand Name: ARTHREX DRIVER, T10 HEXALOBE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 15462262
• Report Number: 15462262
• Device Sequence Number: 4281267
• Product Code: MDM
• UDI-Device Identifier: 00888867053045
• UDI-Public: 00888867053045
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2022
• Report Date (Section F): 09/12/2022

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: AR-8944DH
• Device Catalogue Number: AR-8944DH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/12/2022