FDA Adverse Event Malfunction Summary report: N

4.0MM CANNULATED SCREW

MDR report key: 3876156 · Received June 9, 2014

Report

Report Number
3876156
Event Type
Malfunction
Date Received
June 9, 2014
Report Date
June 9, 2014
Manufacturer
SYNTHES (USA) PRODUCTS LLC
Product Code
HWC
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

DOCTOR WAS PERFORMING A RIGHT PATELLA OPEN REDUCTION INTERNAL FIXATION. THE FRACTURE WAS ACTUALLY PRETTY SIMPLE. THE SURFACE AREA OF THIS PIECE WAS PROBABLY ABOUT THE SIZE OF A QUARTER, BUT THERE WAS A VERY THICK CARTILAGE THAT WAS VISIBLE AND THE CARTILAGE LOOKED TO BE INTACT. HE WAS ABLE TO APPROXIMATE THIS TO THE BODY OF THE PATELLA WITH SOME REDUCTION CLAMPS AND A SUTURE THROUGH THE SOFT TISSUES ANTERIORLY. HE MADE SURE THAT HE REMOVED ALL OF THE PERIOSTEUM FROM THE FRACTURE SITE. HE THEN PLACED 2 K-WIRES ACROSS THE FRACTURE FRAGMENT AND INTO THE BED OF THE PATELLA, VERIFIED THE POSITION OF THE K-WIRES AND ADVANCED A COUPLE OF 4-0 CANNULATED SCREWS ACROSS THESE. X-RAYS SHOWED THAT WHEN THE SECOND SCREW WAS ADVANCED, ONE OF THE THREADS COMPLETELY DELAMINATED OFF OF THE SHAFT OF THE SCREW AND IT HAD MIGRATED INTO THE KNEE JOINT. HE IMMEDIATELY BACKED THIS OUT AND AS HE BACKED OUT, THE THREAD REMOVED ITSELF OUT OF THE KNEE JOINT, BUT THERE WERE SOME METAL FILINGS THAT WERE LEFT WITHIN THE PATELLA, RIGHT AT THE LEVEL OF THE CARTILAGE BONE BORDER ON THE INFERIOR SURFACE NEAR THE FRACTURE SITE. HE ELECTED NOT TO GO IN AND TRY TO REMOVE THESE PIECES AS IT WAS OBVIOUS THAT IT WAS NOT UP IN THE CARTILAGE AND WAS RIGHT AT THE BONE INTERFACE AND THEY ARE VERY SMALL PIECES. HE THEN REDIRECTED THE SECOND K-WIRE AND USED A NEW SYNTHES 4-0 CANCELLOUS PARTIALLY THREADED SCREW. HE WAS ABLE TO ADVANCE THAT AND GOT EXCELLENT PURCHASE AND REDUCTION OF THE FRACTURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
334075 4.0MM CANNULATED SCREW SCREW, FIXATION, BONE HWC SYNTHES (USA) PRODUCTS LLC * *

Patients

Seq Age Sex Outcome Treatment
1 47 YR