FDA Adverse Event
Malfunction
Summary report: N
REPAIR SPECIAL SYS 6 SAG SAW
MDR report key: 2241632
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03211
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- July 29, 2011
- Report Date
- July 29, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION THE DEVICE RAN IN SAFE MODE. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS CORROSION BUILD-UP ON THE LOCKING CAM AND LOCKING CAM PIN, WHICH WERE EACH REPLACED ALONG WITH OTHER COMPONENTS.
Description of Event or Problem · 1
THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION THE DEVICE RAN IN SAFE MODE. THERE WAS NO PATIENT 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 | REPAIR SPECIAL SYS 6 SAG SAW | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |