MAUDE Adverse Event Report: ARTHREX, INC. SCREWDRIVER, T15 HEXALOBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SCREWDRIVER, T15 HEXALOBE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the drive feature was found to be twisted.It was also found to be broken and missing approximately 1/16 in.The distal end surface of the broken driver is corroded.The cause of the twisted and broken drive feature is undetermined, however a likely cause is over-torquing the device.
Event or Problem Description
It was reported the below instrument need to be replaced.Qty(1) ar-9623 ¿ threaded, qty(1) ar-8943-10 ¿ torqued.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: SCREWDRIVER, T15 HEXALOBE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12506022
• Report Number: 1220246-2021-03661
• Device Sequence Number: 4231009
• Product Code: LXH
• UDI-Device Identifier: 00888867052208
• UDI-Public: 00888867052208
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/21/2021

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, T15 HEXALOBE
• Device Catalogue Number: AR-8943-10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1