FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE SAG SAW
MDR report key: 1894690
·
Received November 5, 2010
Report
- Report Number
- 1811755-2010-01592
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 8, 2010
- Report Date
- October 8, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A BLACK SUBSTANCE CAME OUT OF HANDPIECE DURING USE. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORTED ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. MULTIPLE ATTEMPTS TO GATHER ADD'L INFO FROM THE CUSTOMER WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE SAG SAW | SURGICAL INSTRUMENTS MOTORS AND ACCESSORIES/ATTACHM | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |