FDA Adverse Event
Malfunction
Summary report: N
STRAIGHT LONG SABER ATTACHMENT
MDR report key: 2233163
·
Received July 22, 2011
Report
- Report Number
- 1811755-2011-02649
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 24, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR AND AN EVAL IS ANTICIPATED. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT ATTACHMENT WAS OVERHEATING AROUND THE BEARINGS WHILE CUTTING BONE DURING A SPINE PROCEDURE. THE ATTACHMENT WAS REPLACED DURING A BREAK IN THE CASE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRAIGHT LONG SABER ATTACHMENT | HBE | STRYKER INSTRUMENTS KALAMAZOO | 10309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |