FDA Adverse Event
Malfunction
Summary report: N
CORE MICRO DRILL
MDR report key: 2082073
·
Received April 26, 2011
Report
- Report Number
- 1811755-2011-01422
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT DUPLICATED. FURTHER INVESTIGATION REVEALED A DAMAGED BEARING, PRESS PLUG AND OTHER COMPONENT PARTS. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE MICRO DRILL WAS SENT IN FOR REPAIR BECAUSE IT WAS RUNNING ON ITS OWN. THE EVENT OCCURRED DURING ROUTINE MAINTENANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE MICRO DRILL | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |