FDA Adverse Event
Malfunction
Summary report: N
REMB UNIVERSAL DRIVER
MDR report key: 2754171
·
Received September 12, 2012
Report
- Report Number
- 1811755-2012-03477
- Event Type
- Malfunction
- Date Received
- September 12, 2012
- Date of Event
- August 17, 2012
- Report Date
- August 17, 2012
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE REMB UNIVERSAL DRIVER HEATED UP DURING A CASE. A BACK-UP DEVICE WAS USED TO COMPLETE THE CASE WITHOUT PT OR USER INJURIES, AND THERE WERE NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REMB UNIVERSAL DRIVER | HBE | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |