InjuryJDW
SELF-DRILLING HALF PIN APEX 5MM, 120 X 35MM
Received Dec 21, 2011 · Event occurred Nov 2, 2011
Report 8031020-2011-00289 · MDR key 2389849
Device
Generic name
Implant
Manufacturer
Stryker Osteosynthesis SelzachModel number
NACatalog number
5018-5-120
Lot number
X03657
Product problems
- Break
- Device Dislodged or Dislocated
Patient
55 YR
- No Code Available
Narrative
Description of Event or Problem
THE CUSTOMER VIGILANCE REP, FORWARDED BY FAX BOTH TO STRYKER (B)(4) AND THE COMPETENT AUTHORITY (B)(4) FROM THE SURGEON WHO NOTIFIED US OF THE FOLLOWS: ON (B)(6) 2011 THE SURGEON IMPLANTED A HOFFMANN 2 SYSTEM FOR A TIBIAL OPEN FRACTURE. ON (B)(6) HE FOUND THE PROXIMAL APEX IN THE DISTAL CLAMP BROKEN WITH DISLOCATION OF THE FRACTURE.
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Remedial action
- Other