FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 7 RECIP SAW
MDR report key: 2758205
·
Received September 18, 2012
Report
- Report Number
- 1811755-2012-03534
- Event Type
- Malfunction
- Date Received
- September 18, 2012
- Date of Event
- July 2, 2012
- Report Date
- August 22, 2012
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS AVAILABLE FOR EVAL BUT HAS NOT YET BEEN RECEIVED. ADD'L INFO WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM 7 RECIPROCATING SAW OVERHEATED DURING A TOTAL KNEE PROCEDURE. THE CASE WAS COMPLETED USING THE SAME DEVICE WITHOUT ANY PROCEDURE DELAY. THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 7 RECIP SAW | HWE | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |