FDA Adverse Event
Malfunction
Summary report: N
SYS 6 SAG SAW
MDR report key: 1923892
·
Received December 9, 2010
Report
- Report Number
- 1811755-2010-02001
- Event Type
- Malfunction
- Date Received
- December 9, 2010
- Date of Event
- November 16, 2010
- Report Date
- November 16, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS NOT YET BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PIN ON THE BLADE MOUNT ASSEMBLY OF THE ITEM BROKE. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYS 6 SAG SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |