FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_INSTRUMENTS_PRODUCT
MDR report key: 3142630
·
Received June 3, 2013
Report
- Report Number
- 0001811755-2013-01280
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 22, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT AT THE USER FACILITY THE BATTERY WAS LEAKING. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS;
Additional Manufacturer Narrative · 1
THE QUALITY INVESTIGATION HAS BEEN CLOSED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE USER FACILITY THE BATTERY WAS LEAKING. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE USER FACILITY THE BATTERY WAS LEAKING. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243984 | UNKNOWN_INSTRUMENTS_PRODUCT | ARTHROSCOPE | HRX | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4), CORDLESS DRIVER 3, LOT #0923218063 |