FDA Adverse Event
Malfunction
Summary report: N
REMB RECIP SAW
MDR report key: 2891137
·
Received November 14, 2012
Report
- Report Number
- 1811755-2012-04072
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 15, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE FILED WHEN A QUALITY INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE REMB RECIP SAW WOULD NOT HOLD A BLADE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED USING A RASP BY HAND. THERE WERE NO PT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REMB RECIP SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |