| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA | INSTRUMENT | STRYKER SPINE BORDEAUX | LXH | NA | 48511906B | 109528 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-09-14 | 0 |
Patient 1
HOLD - SDAIT WAS REPORTED THAT, "REFLEX HYBRID REVISION DRIVER DRAW ROD TIP BROKE OFF DURING REMOVAL OF SCREW. SCREW HAD ALREADY CLEARED THE LOCKING RING. TIP WAS VISIBLE INSIDE. REMOVED SCREW AND DISPOSED OF. USED BACK UP REVISION DRIVER TO PROCEED WITH NO DELAY IN THE PROCEDURE AND NO LOST OPERATING ROOM TIME."
Patient 1
METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS: AFTER VISUAL INSPECTION, THE TIP WAS CONFIRMED TO BE BROKEN. MANUFACTURING RECORD REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED DURING THE MANUFACTURING. COMPLAINT HISTORY ANALYSIS: 90 PREVIOUS RECORDS HAVE BEEN RECEIVED INVOLVING 93 UNITS. INVESTIGATIONS INTO PAST COMPLAINTS CONCLUDED THAT THE FAILURES WERE THE RESULT OF USER-ERROR I.E. OVER-ANGULATION. RISK ASSESSMENT: THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PATIENT OR OF ANY DELAYS IN SURGERY. THE REFLEX-HYBRID SCREW EXTRACTOR INNER SHAFT IS MADE OF IMPLANT GRADE BIOCOMPATIBLE STAINLESS STEEL TO MITIGATE THE RISK OF BROKEN TIPS REMAINING INSIDE THE PATIENT SHOULD THE DEVICE BREAK DURING SURGERY. CONCLUSION: THE INSTRUMENT FAILURE IS BELIEVED TO BE THE RESULT OF USER-ERROR. THE SURGICAL TECHNIQUE STATES THAT PIVOTING OR ANGULATION OF THE INSTRUMENT MUST BE AVOIDED AS THIS CAN CAUSE BENDING OR BREAKING OF THE INNER SHAFT.