MalfunctionHWL
CORTICAL SCREW 2.3 X 22 MM, HEX 1.5 MM, TITANIUM
Received May 9, 2005 · Event occurred Apr 22, 2005
Report 1220246-2005-00081 · MDR key 600571
Device
Generic name
Plate Screw
Manufacturer
Arthrex, Inc.Model number
AR-13120T-22Catalog number
AR-13120T-22
Lot number
UNK
Product problems
- Break
- Device, or device fragments remain in patient
Patient
*
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
SCREW BROKE WHILE IT WAS APPROX HALF WAY INSERTED AT THE FIFTH THREAD DOWN FROM THE HEAD. THE SURGEON STATED THAT IT BROKE DUE TO A TORSIONAL LOAD. THE LOT NUMBER WAS NOT PROVIDED AND IT IS UNK IF THE IMPLANT BROKEN WAS PART # AR-13120T-22 OR AR-13120T-24. IT WAS REPORTED THAT THE TIP OF THE IMPLANT COULD NOT BE RETRIEVED AND WAS LEFT SECURELY IN THE PT'S BONE. SURGEON REPORTED NO ADVERSE CONSEQUENCES AS A RESULT OF EVENT.