FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE, TIBIA
MDR report key: 2020067
·
Received March 10, 2011
Report
- Report Number
- 9610622-2011-00106
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 24, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
THE TARGET DEVICE FOR THE T2 TIBIA NAIL ALLOWED THE T2 NAIL TO CONNECT TO THE DEVICE IN THE REVERSE, NON-ANATOMICAL POSITION. THIS DEVICE WAS CHECKED BY THE SCRUB TECH, SURGEON AND REP WITH THE DRILL SLEEVES AND DRILL BIT TO ENSURE THE HOLE WOULD STILL TARGET. THEY DID. THE SURGEON THEN QUESTIONED IF INDEED IT WAS CORRECT, AND UPON REFERRING TO THE OPERATIVE TECHNIQUE AGAIN, THEY REALISED THEY HAD IT ON THE TARGET DEVICE INCORRECTLY. THE CONNECTION FROM THE NAIL TO THE TARGET DEVICE WAS FIXED AND THEN IMPLANTED TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE, TIBIA | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |