FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 6 SAGITTAL SAW
MDR report key: 2090489
·
Received April 19, 2011
Report
- Report Number
- 1811755-2011-01320
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 24, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS REC'D AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION, THE DEVICE RAN WITHOUT THE TRIGGER BEING ACTIVATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE TRIGGER ASSEMBLY AND E-BOX, WHICH WERE EACH REPLACED ALONG WITH OTHER COMPONENTS. SERVICE DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE, AND IT WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION, THE DEVICE CONTINUED TO RUN ON ITS OWN. THERE WAS NO PT INVOLVEMENT DURING THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 6 SAGITTAL SAW | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |