FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 7 STERNUM SAW
MDR report key: 4110379
·
Received September 23, 2014
Report
- Report Number
- 0001811755-2014-03329
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- August 20, 2014
- Report Date
- August 31, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED.
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592011 | SYSTEM 7 STERNUM SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | HWE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |