FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER BLADE, T7
MDR report key: 2974066
·
Received February 22, 2013
Report
- Report Number
- 0008010177-2013-00020
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- January 28, 2013
- Report Date
- January 29, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-FREIBURG
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY DEVICE NOT YET RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Additional Manufacturer Narrative · 1
THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE PRODUCT SPECIFIC EXAMINATIONS WHICH ARE INDISPENSABLE IN SUCH CASES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THE REPORTED EVENT CAN NOT BE DETERMINED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
SCREWS REPEATEDLY GOT DETACHED FROM THE SCREWDRIVER AND WERE FALLING INTO THE WOUND BEFORE THEY COULD BE TIGHTENED.
Description of Event or Problem · 1
SCREWS REPEATEDLY GOT DETACHED FROM THE SCREWDRIVER AND WERE FALLING INTO THE WOUND BEFORE THEY COULD BE TIGHTENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78227 | SCREWDRIVER BLADE, T7 | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS-FREIBURG | TBA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |