FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 2 HANDPIECE
MDR report key: 3051627
·
Received April 10, 2013
Report
- Report Number
- 0001811755-2013-00756
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 18, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
ALTHOUGH NO METAL SHAVINGS WERE OBSERVED DURING EVALUATION, CORROSION WAS FOUND THROUGHOUT THE HANDPIECE WHICH COULD HAVE BEEN INTERPRETED TO BE METAL SHAVINGS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE THE CORDLESS DRIVER 2 HANDPIECE HAD METAL SHAVINGS COMING OUT OF THE DEVICE. NO ADVERSE CONSEQUENCES TO THE USER OR PATIENT WERE REPORTED, AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE THE CORDLESS DRIVER 2 HANDPIECE HAD METAL SHAVINGS COMING OUT OF THE DEVICE. NO ADVERSE CONSEQUENCES TO THE USER OR PATIENT WERE REPORTED, AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149516 | CORDLESS DRIVER 2 HANDPIECE | ARTHROSCOPE | HRX | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN PIN COLLET |