FDA Adverse Event Malfunction Summary report: N

CHARLOTTE MULTI-USE COMPRESSION SCREW

MDR report key: 1081150 · Received July 15, 2008

Report

Report Number
1081150
Event Type
Malfunction
Date Received
July 15, 2008
Date of Event
June 4, 2008
Report Date
July 15, 2008
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Product Code
HWC
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PT UNDERGOING OSTEOTOMY OF FIRST METATARSAL, RIGHT AND FIRST MR JOINT FUSION. OPERATIVE REPORT READS AS FOLLOWS: PERIOSTEAL INCISION WAS THEN MADE AND AN OPENING WEDGE OSTEOTOMY WAS MADE AT THE BASE OF THE FIRST METATARSAL UTILIZING A DARCO PLATE FROM THE WRIGHT MEDICAL SET. THE PLATE WAS FIXATED IN TEMPORARILY TO ENSURE GOOD REDUCTION OF THE INNER METATARSAL ANGLE WITH THE OPENING WEDGE OSTEOTOMY. ONCE THIS WAS ACHIEVED, PERMANENT FIXATION WAS PLACED AND BONE GRAFT WAS PLACED INTO THAT OPENING WEDGE AND THAT WAS ALLOGRAFT. GOOD REDUCTION OF THE IM ANGLE WAS NOTED BUT, PRIOR TO COMPLETING THAT, WE HAD TO RESECT THE FIRST MP JOINT SO THAT WE COULD CLOSE THE IM ANGLE DOWN ADEQUATELY WITHOUT ABUTMENT TO THE SECOND TOE. THE FIRST MP JOINT WAS SIGNIFICANTLY ARTHRITIC AND THE ARTICULAR SURFACE WAS RESECTED. TEMPORARY FIXATION AGAIN WAS ATTEMPTED; HOWEVER, ONE OF THE SCREWS BROKE INTRA-OPERATIVELY INTO THE MEDULLARY BONE. AT THAT POINT, THE SURGEON DETERMINED IT WAS NOT NECESSARY TO REMOVE THAT FRAGMENT AS IT WAS INTRA-MEDULLARY AND IT WOULD HAVE CREATED MORE DAMAGE TO THE TISSUE TRYING TO RETRIEVE IT. AT THAT POINT, THE SURGEON DETERMINED THAT HE NEEDED STABILITY FROM ANOTHER PLATE SO ANOTHER DARCO WEDGE PLATE WAS PLACED OVER THE OSTEOTOMY AND GOOD ALIGNMENT WAS NOTED. INTRA-OPERATIVE FILMS CONFIRMED GOOD INTERNAL FIXATIVE PLACEMENT AS WELL. INFORMATION PROVIDED POST-OP, THERE WAS NO IMPEDANCE IN THE JOINT, AND THE SCREW WAS IN SOLID BONE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CHARLOTTE MULTI-USE COMPRESSION SCREW HARDWARE, ORTHOPEDIC, SCREW HWC WRIGHT MEDICAL TECHNOLOGY, INC. * UNK

Patients

Seq Age Sex Outcome Treatment
1 57 YR