FDA Adverse Event Malfunction Summary report: N

UNIVERSAL DRIVER SHAFT

MDR report key: 2082218 · Received May 3, 2011

Report

Report Number
2082218
Event Type
Malfunction
Date Received
May 3, 2011
Date of Event
April 27, 2011
Report Date
May 3, 2011
Manufacturer
STRYKER
Product Code
HXX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NJ, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

ELECTIVE RIGHT TOTAL HIP REPLACEMENT WAS PERFORMED DUE TO LONG STANDING HISTORY OF SEVERE HIP ARTHRITIS AND PAIN. MALE PT FAILED CONSERVATIVE MEASURES AND ELECTED FOR A RIGHT-SIDED HIP REPLACEMENT. REAMING WAS COMPLETED TO THE APPROPRIATE SIZE. A TRITANIUM CUP WAS INSERTED, IT WAS FIXED INTO PLACE WITH TWO SCREWS BY A HAND TIGHTEN MANEUVER WITH THE PROPER TENSION USING THE STRYKER ORTHOPAEDICS SCREWDRIVER. IN PERFORMING THIS FUNCTION, THE TIP OF THE SCREWDRIVER BROKE OFF INSIDE OF THE SCREW. ATTEMPTS TO DISLODGE BROKEN SCREW TIP WITH MULTIPLE INSTRUMENTS WERE UNSUCCESSFUL. DETERMINED THE PIECE WAS COLD-WELDED INTO THE SCREW HEAD, COMPLETELY FLUSH WITH THE SCREW HEAD. SCREW WAS FULLY SEATED INTO THE BONE AND TRITANIUM CUP AT THIS TIME. GIVEN THE POTENTIAL HARM OF ATTEMPTING TO REMOVE THE SCREW AND POTENTIALLY FRACTURING THE ACETABULUM OR PELVIS, IT WAS ELECTED TO LEAVE THIS RETAINED PIECE OF THE SCREWDRIVER BEHIND GIVEN THAT IT WAS COMPLETELY COVERED WITH A POLYETHYLENE LINER INSERT, COVERING THE TRITANIUM CUP AND SCREWS. THUS, THERE WOULD BE NO RISK OF MIGRATION WHICH COULD CAUSE HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER DIFFICULTIES AND THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM AND THEN TO THE MEDICAL/SURGICAL FLOOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNIVERSAL DRIVER SHAFT SCREWDRIVER HXX STRYKER 2107-1015 FSA9383

Patients

Seq Age Sex Outcome Treatment
1 55 YR