FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1970345
·
Received January 18, 2011
Report
- Report Number
- 1811755-2011-00144
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- September 8, 2010
- Report Date
- September 8, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DURING THE QUALITY INVESTIGATION TESTING, THE DEVICE EXCEEDED THE MAXIMUM ALLOWABLE TEMPERATURE ON THE SPINDLE HOUSING. FURTHER INVESTIGATION REVEALED CORROSION INSIDE THE MOTOR ASSEMBLY AND THERE WAS NO LUBE INSIDE THE BEARING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
A STRYKER CORE IMPACTION DRILL WAS SENT TO STRYKER SERVICE WITH A REQUEST FOR REPAIRS AND IT OVERHEATED DURING QUALITY INVESTIGATION TESTING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE IMPACTION DRILL | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |