FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
MDR report key: 3901999
·
Received June 30, 2014
Report
- Report Number
- 0001811755-2014-02311
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- June 14, 2014
- Report Date
- June 16, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- GFF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED. THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED PRIOR TO THE CASE THE DRILL BIT BROKE OFF INSIDE OF THE ATTACHMENT. THERE WERE NO ADVERSE CONSEQUENCES OR SURGICAL DELAY AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED PRIOR TO THE CASE THE DRILL BIT BROKE OFF INSIDE OF THE ATTACHMENT. THERE WERE NO ADVERSE CONSEQUENCES OR SURGICAL DELAY AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380040 | UNKNOWN_INSTRUMENTSTIRE_PRODUCT | UNKNOWN | GFF | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) LOT 13356| (B)(4) LOT 13356 |