T8 STICK FIT HEXALOBE DRIVER

Report

Report Number: 3025141-2024-00545
Event Type: Malfunction
Date Received: July 19, 2024
Date of Event: May 27, 2024
Report Date: July 19, 2024
Manufacturer: ACUMED, LLC
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE REPORTED SCREW WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE MODEL NUMBER AND BATCH/LOT NUMBER OF THE SCREW IS UNKNOWN. HOWEVER, THE REPORTED DRILL WAS RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE T8 STICK FIT HEXALOBE DRIVER (PART NUMBER 80-0729, BATCH NUMBER 597274) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE DRIVER SHOWED COUNTERCLOCKWISE TWISTING AT THE TIP, WHICH SUGGESTED THE DEFORMATION MAY HAVE OCCURRED DURING REMOVAL. A POSSIBLE CAUSE OF A TWISTING DEFORMATION IS EXCESSIVE TORQUE APPLIED TO THE PART. FUNCTIONAL TESTING WITH A 2.7MM HEXALOBE SCREW WAS PERFORMED, WHICH REVEALED THE DRIVER COULD STILL SEAT INTO THE SCREW HEAD. BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem · 0

IT WAS REPORTED DURING SURGERY WHEN THE SURGEON USED SCREWDRIVER TO REMOVE THE SCREW FROM THE PLATE, THE TIP OF THE SCREWDRIVER TWISTED AND DEFORMED. THE SURGEON SAID IT WAS EASILY DEFORMED, EVEN THOUGH HE DID NOT ROTATE THE SCREWDRIVER WITH THAT MUCH FORCE. THE SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE OF THE SAME MODEL AFTER A 5-MINUTE DELAY. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2024-00546 FOR THE SCREW INVOLVED IN THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1551314	T8 STICK FIT HEXALOBE DRIVER	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	LXH	ACUMED, LLC	80-0759	597274

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown