FDA Adverse Event
Malfunction
Summary report: N
REPAIR SYS6 DT ROTARY
MDR report key: 1902884
·
Received November 12, 2010
Report
- Report Number
- 1811755-2010-01674
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 15, 2010
- Report Date
- October 15, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR AND THE LEAKING COULD NOT BE DUPLICATED. REPAIRS WERE PERFORMED ON THE DEVICE AND IT WAS RETURNED TO THE ACCOUNT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS LEAKING BLOOD AND THERE WERE NO ADVERSE CONSEQUENCES. ATTEMPTS TO COLLECT ADD'L INFO FROM THE ACCOUNT HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR SYS6 DT ROTARY | INSTRUMENT, SURGICAL, ORTHOPAEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |