FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER BLADE, T7, AO
MDR report key: 2002564
·
Received January 28, 2011
Report
- Report Number
- 8010177-2011-00019
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- December 28, 2010
- Report Date
- January 5, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE TORSIONAL DEFORMATIONS WITH THE 21 TIPS OF THE DRIVER BLADES WHEN THEY WERE CHECKED IN DISTRIBUTION CENTER, AND 1 TIP OF THE DRIVER BLADE WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREWDRIVER BLADE, T7, AO | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS FREIBURG | NA | AA05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |