FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 3
MDR report key: 2130046
·
Received May 5, 2011
Report
- Report Number
- 1811755-2011-01621
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- March 3, 2011
- Report Date
- April 8, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GET
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE SAFETY BAR WAS DENTED AND GOUGING INTO THE TRIGGER SHAFT AND CAUSING THE TRIGGER TO STICK. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A STICKY TRIGGER. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDLESS DRIVER 3 | GET | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |