FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER BLADE, T7, AO
MDR report key: 2211667
·
Received August 6, 2011
Report
- Report Number
- 8010177-2011-00233
- Event Type
- Malfunction
- Date Received
- August 6, 2011
- Date of Event
- July 14, 2011
- Report Date
- July 14, 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 PROGRESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
UPON INSPECTION OF THE RETURNED LOANER KIT FROM THE HOSP IT WAS FOUND THAT THE TIP OF THE SCREW 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 | AB01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |