FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 6 SAGITTAL SAW
MDR report key: 3970715
·
Received July 31, 2014
Report
- Report Number
- 0001811755-2014-02738
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 9, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED DISASSEMBLY WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY IT WAS FOUND THAT THE TRIGGER HOUSING WAS CRACKED AT THE SCREW BOSS, WHICH CAN LEAD TO THE REPORTED EVENT AND CAN BE CAUSED BY A MATERIAL FATIGUE ISSUE OR IMPACT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE USER FACILITY THE TRIGGER OF THE DEVICE DISASSEMBLED, CAUSING THE COMPRESSION SPRING AND STRAIGHT PIN TO DISASSEMBLE. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446959 | SYSTEM 6 SAGITTAL SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | HWE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |