MAUDE Adverse Event Report: ARTHREX, INC. SCREWDRIVER, T10 HEXALOBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SCREWDRIVER, T10 HEXALOBE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2021
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
It was reported the doctor was tightening a 2.7 screw in distal fibula plate and on the last quarter turn the driver tip broke in the screw head.The doctor was able to remove the broke part from the screw with no issue.The procedure was completed successfully.

• Brand Name: SCREWDRIVER, T10 HEXALOBE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12466904
• Report Number: 1220246-2021-03626
• Device Sequence Number: 11739301
• Product Code: LXH
• UDI-Device Identifier: 00888867052185
• UDI-Public: 00888867052185
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/14/2021

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: SCREWDRIVER, T10 HEXALOBE
• Device Catalogue Number: AR-8943-08
• Device Lot Number: 1391911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1