FDA Adverse Event
Malfunction
Summary report: N
REPAIR SYS 4 RECIP/STERNUM SAW
MDR report key: 1890642
·
Received October 25, 2010
Report
- Report Number
- 1811755-2010-01487
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- September 25, 2010
- Report Date
- September 27, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR AND THE EVAL FOUND NO SIGN OF LEAKAGE. THERE IS SMALL AMOUNT OF MINERAL DEPOSIT BUILD UP ON THE INSIDE REAR PORTION OF HANDLE. THIS REPORT WILL BE UPDATED IF ADD'L INFO FROM THE INVESTIGATION REQUIRES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE WAS LEAKING AN UNK SUBSTANCE. THIS WAS FOUND PRIOR TO A CASE WHILE TESTING. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR SYS 4 RECIP/STERNUM SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |