FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE SABER DRILL
MDR report key: 1853725
·
Received August 30, 2010
Report
- Report Number
- 1811755-2010-01055
- Event Type
- Malfunction
- Date Received
- August 30, 2010
- Date of Event
- July 19, 2010
- Report Date
- July 19, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DRILL WAS RECEIVED BY THE MANUFACTURER, HOWEVER THE COMPLAINT COULD NOT BE REPLICATED. BASED ON THE RESULTS OF THE DEVICE EVALUATION, THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE EQUIPMENT EVALUATION CONDUCTED BY THE MANUFACTURER'S SALES REPRESENTATIVE, A DRILL ATTACHMENT HEATED UP. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE SABER DRILL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |