DEPUY SYNTR
Received Sep 8, 2016 · Event occurred Aug 23, 2016
Report MW5064643 · MDR key 5939588
Device
Generic name
1.25 Kirschner Guidewire
Manufacturer
Depuy SynthesModel number
NACatalog number
292.12
Lot number
NA
Product problems
- Break
Patient
78 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
A (B)(6) YEAR OLD FEMALE FELL INJURING HER RIGHT WRIST, HAND AND FINGERS. PT. WAS IN THE OPERATING ROOM FOR ORIF OF RIGHT DISTAL RADIUS FRACTURE. AS PER SURGEON'S OP NOTE ADDENDUM: IT WAS NOTED DURING THE FINAL X-RAYS (FLUOROSCOPY) THAT ONE OF THE GUIDE PINS/WIRE (1.25 KIRSCHNER) THAT WAS USED TO HOLD THE PLATE IN PLACE HAD BROKEN BELOW THE PLATE. THE PLATE WAS ALREADY SCREWED INTO POSITION. THE PIN REMAINS INSIDE THE BONE. SURGEON DETERMINED IT WOULD BE LEFT IN PLACE AND WOULD NOT AFFECT HEALING OF THE FRACTURE. INCIDENT DISCLOSED TO PT. SYNTHES REP, (B)(4) PRESENT AND WILL REPORT TO COMPANY. SCREWS: USED. ONE SCREW BNE316L SS L14MM CATALOG 202.874; ONE SCREW 2.4 LCK SC CATALOG 212.818 18 MM; THREE SCREWS BNE 316L SS L16MM CATLOG 212.816 16 MM; ONE SCREW BNE 316L SS L20MM CATALOG 212.820 20 MM; TWO SCREWS BNE 316L SS 12MM CATALOG 202.872 12MM. REFERENCE # (B)(4).