FDA Adverse Event
Malfunction
Summary report: N
REMB UNIVERSAL DRIVER
MDR report key: 3840253
·
Received May 30, 2014
Report
- Report Number
- 0001811755-2014-01978
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- May 5, 2014
- Report Date
- May 5, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED EVENT WAS DUPLICATED. UPON DISASSEMBLY FOR VISUAL INSPECTION, THE HANDPIECE HAD A WORN TRIGGER SHAFT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE REMB UNIVERSAL DRIVER WAS ABLE TO OPERATE IN REVERSE WHILE IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318252 | REMB UNIVERSAL DRIVER | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |