VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES
Report
- Report Number
- 0008010177-2013-00198
- Event Type
- Malfunction
- Date Received
- August 27, 2013
- Date of Event
- July 30, 2013
- Report Date
- July 31, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-FREIBURG
- Product Code
- HRS
- PMA / PMN Number
- K040022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
EVALUATION SUMMARY: CONSIDERING THE HANDLING TEST IN WHICH A NEW RELATED AIMING BLOCK COULD BE CORRECTLY ATTACHED TO THE RETURNED PLATE BY A NEW FIXATION PIN THE REPORTED EVENT COULD NOT BE CONFIRMED. INVESTIGATION 230445 (PLATE WITH ARTICLE # 54-25384S): THE VISUAL INVESTIGATION OF THE RETURNED PLATE REVEALED THAT ONE HOLE SHOWS SIGNS OF USE AND PRESSURE MARKS MOST LIKELY FROM SEVERAL ATTEMPTS TO FIX THE AIMING BLOCK TO THE PLATE BY THE FIXATION PIN. THE HANDLING TEST - PERFORMED WITH THE RETURNED PLATE AND NEW TEST SAMPLES (FIXATION PIN AND RELATED AIMING BLOCK) REVEALED A CORRECT ASSEMBLING AND DISASSEMBLING FUNCTION OF THE NEW AIMING BLOCK AND NEW FIXATION PIN TO THE RETURNED PLATE. THE SUBSEQUENT INSERTING OF THE APPROPRIATE K-WIRE INTO THE AIMING BLOCK / PLATE CONSTRUCTION COULD BE ALSO PERFORMED CORRECTLY. BASED ON INVESTIGATION THE ROOT CAUSE WHY THE MENTIONED (NOT RETURNED) AIMING BLOCK COULD NOT BE ATTACHED TO THE RETURNED PLATE WAS ATTRIBUTED TO A USER RELATED HANDLING ISSUE. ALSO THE BREAKAGE OF EACH STOP PIN OF THE TWO RETURNED FIXATION PINS POINTS TO A USER RELATED HANDLING ISSUE. INVESTIGATION 230448 (TWO FIXATION PINS WITH ARTICLE # 56-01210): WITHIN THE VISUAL INVESTIGATION OF THE TWO RETURNED FIXATION PINS IT WAS DETERMINED THAT EACH STOP PIN, LASER-WELDED WITH THE EXPANDING SLEEVE, WAS BROKEN OFF AND THEREFORE DETACHED. THE BROKEN OFF STOP PINS WERE NOT RETURNED. EACH FRACTURE SURFACE OF THE WELDING SEAMS AT THE EXPANDING SLEEVES SHOWS THE APPEARANCE OF A FORCED RUPTURE. FURTHERMORE EACH STOP BAR OF THE SCREWS, COUNTERPART OF THE STOP PIN, SHOWS HEAVY, PLASTIC DEFORMATIONS. BECAUSE OF THE TOO HIGH TORSIONAL FORCES, SEVERAL TIMES ACTED DURING THE APPLICATION, TOO HIGH BENDING FORCES OCCURRED UPON TO THE STOP PINS, LEADING FINALLY TO THE BREAKAGE OF THE LASER-WELDING SEAM BETWEEN THE STOP PIN AND EXPANDING SLEEVE. BASED ON THE CURRENTLY PERFORMED INVESTIGATION AND BASED ON PREVIOUS EVALUATIONS WITH SEM MICROGRAPH THE ROOT CAUSE OF THE BREAKAGE OF EACH STOP PIN WAS ATTRIBUTED TO A USER RELATED ISSUE. BECAUSE OF TOO HIGH BENDING FORCES, EACH LASER-WELDED SEAM BETWEEN THE STOP PIN AND EXPANDING SLEEVE OF BOTH RETURNED FIXATION PINS WAS BROKEN OFF IN LOW CYCLE FATIGUE MODE WITH MUCH EVIDENCE OF A FORCED RUPTURE. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED ISSUES COULD NOT BE FOUND IN THE INVESTIGATION. THEREFORE NO CORRECTIVE ACTION WAS DEEMED NECESSARY AT THIS TIME.
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
DURING VARIAX DR SURGERY, THE AIMING BLOCK COULD NOT BE ATTACHED TO THE PLATE. ATTACHING WAS ATTEMPTED MANY TIMES, THEN PIN IS DAMAGED. AFTER THAT THE SURGEON USED SAME SIZE OTHER PLATE, THE AIMING BLOCK COULD BE ATTACHED TO THE PLATE EASILY.
DURING VARIAX DR SURGERY, THE AIMING BLOCK COULD NOT BE ATTACHED TO THE PLATE. ATTACHING WAS ATTEMPTED MANY TIMES, THEN PIN IS DAMAGED. AFTER THAT THE SURGEON USED SAME SIZE OTHER PLATE, THE AIMING BLOCK COULD BE ATTACHED TO THE PLATE EASILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420699 | VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS-FREIBURG | 1000080674 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |