FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE)
MDR report key: 3002937
·
Received March 13, 2013
Report
- Report Number
- 0008010177-2013-00037
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- February 16, 2013
- Report Date
- February 18, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K022185
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION AND PERFORMED INTERNAL INVESTIGATION, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THERE WERE NO INDICATIONS FOUND FOR ANY MATERIAL OR MANUFACTURING RELATED ISSUE. (B)(4): DEVICE NOT RETURNED.
Description of Event or Problem · 1
THE SCREW HEAD BROKE DURING INSERTION.
Description of Event or Problem · 1
THE SCREW HEAD BROKE DURING INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104821 | LOCKING SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE) | SCREW | JEY | STRYKER OSTEOSYNTHESIS-FREIBURG | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |