FDA Adverse Event
Malfunction
Summary report: N
SINGLE TRIGGER ROTARY
MDR report key: 3933212
·
Received July 14, 2014
Report
- Report Number
- 0001811755-2014-02508
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 17, 2014
- Report Date
- June 18, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT WITHOUT AN EVALUATION OF THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE TRIGGER OF THE DEVICE DISASSEMBLED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT. THE PROCEDURE WAS DELAYED, BUT IT WAS NOT REPORTED THAT THE DELAY WAS CLINICALLY SIGNIFICANT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409273 | SINGLE TRIGGER ROTARY | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | HWE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |