FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 2 HANDPIECE
MDR report key: 2000171
·
Received February 18, 2011
Report
- Report Number
- 1811755-2011-00539
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR SERVICE AND EVAL. THE INITIAL COMPLAINT COULD NOT BE VERIFIED. BASED ON THE INVESTIGATION DETAILS, THE REAR MOTOR ASSEMBLY HAD HEAT DAMAGE. THIS WAS REPLACED ALONG WITH OTHER COMPONENTS. THE DEVICE WAS REPAIRED AND WILL BE RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE SMOKES. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDLESS DRIVER 2 HANDPIECE | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM | HRX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |