TI VECTRA-T(TM) PLATE 2 LEVEL/32MM
Report
- Report Number
- 8030965-2013-05251
- Event Type
- Malfunction
- Date Received
- November 12, 2013
- Report Date
- October 17, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- KWQ
- PMA / PMN Number
- K051665
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
MANUFACTURING EVALUATION - THE PLATE WAS RECEIVED WITH ALL WISHBONE CLIPS ASSEMBLED IN THE HOLES. WISHBONE CLIPS IN HOLES B AND C1 WERE VISUALLY DAMAGED POST PRODUCTION. NO VISUAL DEFECTS RELATED TO THE MANUFACTURING PROCESS WERE NOTED. THE RELEVANT FEATURES WERE INSPECTED BEFORE AND AFTER DISASSEMBLY OF THE WISHBONE CLIPS BASED ON THE INSPECTION PROCEDURES. ALL RELEVANT MEASURABLE FEATURES MEET SPECIFICATION. HOWEVER, THE WISHBONE CLIPS ON HOLES B AND C1 COULD NOT BE MEASURED DUE TO POST MANUFACTURING DAMAGES. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.
ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT. TWO TITANIUM VECTRA-T PLATES, TWO-LEVEL (PART# 450.563 LOT#S 3400258, 8028374) AND ONE 4.0MM VARIABLE ANGLE SCREW WERE RETURNED FOR THE ELGILOY WISHBONE CLIP REPORTEDLY BREAKING DURING FINAL TIGHTENING AND SCREW INSERTION. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE PLATES ARE DESIGNED TO UTILIZE VARIABLE AND FIXED ANGLE SCREWS. THE VARIABLE ANGLE SCREWS HAVE A 28° RANGE IN THE CRANIAL-CAUDAL DIRECTION AND 14° RANGE IN THE MEDIAL-LATERAL DIRECTION. THE WISHBONE CLIPS ARE MADE FROM ELGILOY, ASTM F-1058 GRADE 1 AND ARE REQUIRED TO HAVE A MINIMUM TENSILE STRENGTH OF 1138 MPA. THIS ENSURES BENDING OR BREAKING OF THE CLIPS DOES NOT OCCUR DURING SCREW INSERTION. THE 4.0MM VARIABLE ANGLE SCREW LOCKED TO ONE OF THE RETURNED PLATES SUGGESTS THAT SCREW ORIENTATIONS OUTSIDE OF THE NOMINAL TRAJECTORY WERE PURSUED. THE BREAKING AND DAMAGING OF THE CLIPS REPORTED MAY BE DUE TO SCREW INSERTIONS AND FINAL TIGHTENING AT ANGLES OUTSIDE OF THE RANGE THE PLATES ARE DESIGNED FOR. THIS CAN OCCUR WHEN THE SCREW ARE INSERTED AT SHARP ANGLES IN THE MEDIAL-LATERAL DIRECTION WHERE THE DESIGNED RANGES ARE SMALLER COMPARED TO THE CRANIAL-CAUDAL DIRECTION AND THE WISHBONE CLIPS PROTRUDE FURTHER INTO THE SCREW HOLE. REVIEW OF THE CLIPS FOUND THE DESIGN TO BE ADEQUATE FOR THEIR INTENDED USE. THE COMPLAINT IS INDETERMINATE FROM A DESIGN PERSPECTIVE. (B)(4).
SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.
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
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584422 | TI VECTRA-T(TM) PLATE 2 LEVEL/32MM | KWQ | SYNTHES GMBH | 3400258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |