FDA Adverse Event
Malfunction
Summary report: N
LAG SCREWS, CROSS-PIN, DIAM.2.0X30MM, (5/PACKAGE)
MDR report key: 3033815
·
Received April 3, 2013
Report
- Report Number
- 0008010177-2013-00056
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 11, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K014263
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Additional Manufacturer Narrative · 1
THE RETURNED DEVICE MATCHED THE REPORT, AND THE EVENT WAS CONFIRMED. THE MICROSCOPIC AND MACROSCOPIC INVESTIGATION RESULTS SHOWED THAT THE SCREW BROKE AS A RESULT OF TOO HIGH TORSIONAL FORCES IN FORCED RUPTURE MODE DURING INSERTION. BASED ON THE PERFORMED INVESTIGATION, NO INDICATIONS WERE FOUND FOR ANY MATERIAL OR MANUFACTURING RELATED PROBLEMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LAG SCREW (30 MM) BROKE ON THE LAST SCREW THREAD WHILE BEING INSERTED. SCREW BODY WAS LEFT IN PATIENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LAG SCREW (30 MM) BROKE ON THE LAST SCREW THREAD WHILE BEING INSERTED. SCREW BODY WAS LEFT IN PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136027 | LAG SCREWS, CROSS-PIN, DIAM.2.0X30MM, (5/PACKAGE) | SCREW | JEY | STRYKER OSTEOSYNTHESIS-FREIBURG | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |