FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
MDR report key: 2102557
·
Received May 19, 2011
Report
- Report Number
- 1811755-2011-01823
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 28, 2011
- Report Date
- April 29, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE CUSTOMER SENT THE DEVICE TO A THIRD-PARTY FACILITY FOR REPAIR. THE REPORTED CONDITION OF THE DEVICE SMOKING DURING USAGE CANNOT BE CONFIRMED WITHOUT THE PRODUCT BEING AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN SMOKING DURING A TOTAL KNEE ARTHROPLASTY WHILE THE ACCOUNT WAS TRIALING A COMPETITOR'S BATTERY. THE PROCEDURE WAS CONTINUED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY OR ANY OTHER ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |