NA
Report
- Report Number
- 8010177-2004-00006
- Event Type
- Injury
- Date Received
- April 14, 2004
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- JEY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
PER (B)(6) EVALUATION ON (B)(6) 2004: THE COMPLAINT IS NOT ACCEPTED. USER RELATED. THE COMPLAINT IS NOT ACCEPTED. A TITANIUM FRACTURE PLATE, STRAIGHT, 14 HOLES, WITHOUT BAR, LENGTH 118MM BROKE POSTOPERATIVELY AND WAS RETURNED IN ORDER TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE SAMPLE WAS EXAMINED REGARDING ITS DIMENSIONS AS WELL AS BY LIGHT AND SCANNING ELECTRON MICROSCOPY. THE MEASURED DIMENSIONS ARE IN ACCORDANCE WITH THE SPECIFICATION. THE INVESTIGATION SHOWS THAT THE PLATE BROKE BY EXCEEDING THE MATERIALS STRENGTH IN A FORCED FRACTURE MODE OR AFTER A FEW CYCLES UNDER VERY HIGH LOADS IN LOW CYCLE FATIGUE MODE. THE PLASTIC DEFORMATIONS DURING THE ADAPTATION TO THE ANATOMY OF THE PATIENT LED TO A MASSIVE STRAIN HARDENING / EMBRITTLEMENT, PROMOTING THE BREAKAGE OF THE PLATE. THE SAMPLE ALSO SHOWS DAMAGES CAUSED BY MEDICAL INSTRUMENTS. INDICATION FOR MATERIAL RELATED PROBLEMS WERE NOT FOUND IN THIS INVESTIGATION. FURTHER DETAILS ARE DOCUMENTED IN THE FAILURE ANALYSIS REPORT AND IMAGE DOCUMENTATION (B)(4) ISSUED BY (B)(4), STRYKER LEIBINGER GMBH & CO.KG, DEPT TEST AND ANALYSIS ON (B)(6) 2004.
IT HAS BEEN REPORTED THAT THE PLATE BROKE 2 MONTHS POSTOPERATIVELY. THE FRACTURE OCCURRED DURING MASTICATION. ANY IMPACT RELATED ON THE PATIENT HAD NOT BEEN REPORTED SO FAR. FURTHER INVESTIGATION IS REQUIRED TO CONFIRM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | JEY | STRYKER INSTRUMENTS | 54-15070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |