FDA Adverse Event
Malfunction
Summary report: N
BONE SCREWS, CROSS-PIN, DIAM. 2.0X10MM, (5/PACKAGES)
MDR report key: 2033732
·
Received February 11, 2011
Report
- Report Number
- 8010177-2011-00042
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K022185
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED OBSERVATION COULD NOT BE CONFIRMED, BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE RISK ASSESSMENT RELATED TO THE FAILURE MODE AS REPORTED, REVEALED THAT THE ACTUAL OCCURRENCE LEVEL IS EXCEEDING THE DEFINED/EXPECTED AND ACCEPTED RATE/PROBABILITY OF OCCURRENCE. TO ADDRESS THIS ISSUE, A CAPA WAS OPENED.
Description of Event or Problem · 1
SURGEON WAS INSERTING SCREW INTO PATIENT'S HEAD AND THE TOP OF SCREW BROKE OFF. THEY LEFT THE BOTTOM PART OF SCREW IN PATIENT. ALL STRYKER PRODUCTS WERE USED. PER SALES REPRESENTATIVE, NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONE SCREWS, CROSS-PIN, DIAM. 2.0X10MM, (5/PACKAGES) | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |