MAUDE Adverse Event Report: ARTHREX, INC. LOCK DISTAL FIBULA PLT,SS LFT,4H; PLATE, FIXATION, BONE

Model Number	LOCK DISTAL FIBULA PLT,SS LFT,4H
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
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.
Event or Problem Description
It was reported that during a procedure, the surgeon/scrub tech did not realize they were using a cannulated driver and cross threaded the locking screw into the plate.The torque on the driver broke the driver and the screw and they were unable to get the screw out of the plate.Additional information 4/9/2021: it was reported that during an ankle fracture repair procedure, the surgeon/scrub tech did not realize they were using a cannulated driver and cross threaded the locking screw into the plate.The implant screw was cross threaded into the plate and the whole thing pulled out of the patient¿s bone.The torque on the driver broke the driver and the screw and they were unable to get the screw out of the plate.The case was completed using a new plate, screw and driver.

• Brand Name: LOCK DISTAL FIBULA PLT,SS LFT,4H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11692724
• Report Number: 1220246-2021-02928
• Device Sequence Number: 4168692
• Product Code: HRS
• UDI-Device Identifier: 00888867052512
• UDI-Public: 00888867052512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• 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): 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LOCK DISTAL FIBULA PLT,SS LFT,4H
• Device Catalogue Number: AR-8943BL-04
• Device Lot Number: 105642038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1