FDA Adverse Event
Malfunction
Summary report: N
ELITE 17CM STRAIGHT ATTACHMENT
MDR report key: 5113034
·
Received September 30, 2015
Report
- Report Number
- 0001811755-2015-03596
- Event Type
- Malfunction
- Date Received
- September 30, 2015
- Date of Event
- September 3, 2015
- Report Date
- September 3, 2015
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K143320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS IS IN PROGRESS.
Additional Manufacturer Narrative · 1
UPDATING RECORD BASED ON COMPLETED INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A MANUFACTURER SALES REPRESENTATIVE THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A MANUFACTURER SALES REPRESENTATIVE THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646366 | ELITE 17CM STRAIGHT ATTACHMENT | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |