BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3182367 · Received June 21, 2013

    Report

    Report Number
    2530088-2013-00975
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAVE BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE HEX TIP ON THE RETURNED DEVICE IS WORN AND DISCOLORED. THE HEX WALLS ARE DISTORTED (BENT AND ROUNDED EDGES). DESIGN EVALUATION: THE CANNULATION FEATURE (Ø2.9MM + 0.1 AT DISTAL END) ON THIS DEVICE SHAFT IS NECESSARY FOR PRECISE SCREW PLACEMENT VIA Ø2.5MM GUIDE WIRE. THE DIMENSION FROM THE EXTERIOR WALL OF A HEX FLAT TO HEX FLAT ON THE DISTAL HEX TIP IS 4.0MM -0.02, WHICH IS NECESSARY IN ORDER TO ENGAGE THE 4MM HEX DRIVE RECESS ON CANNULATED SCREWS INCLUDING THE Ø7.3MM CANNULATED SCREWS MENTIONED IN THIS COMPLAINT DESCRIPTION. IN 2002, THE SHAFT MATERIAL WAS CHANGED FROM 440A SS TO 465PH MATERIAL TO REDUCE PROBABILITY OF SHAFT TIPS BREAKING. THE CHANGE TO 465PH ENCOURAGES THE SHAFT TIP TO BEND INSTEAD OF BREAKING. THE BENDING IS A MORE FAVORABLE CONDITION THAN BREAKING FOR THE SURGEON AND THE PATIENT. THE SHAFT COMPONENT OF THE RETURNED DEVICE FOR THIS COMPLAINT WAS MANUFACTURED IN AUGUST 2004 FROM 465 PH. RISK ANALYSIS EVALUATION: THE 4.5MM VA-LCP CURVED CONDYLAR PLATE RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION OF AN INSTRUMENT BENDING AS LESS SEVERE WITH A MODERATE SEVERITY OF HARM 3 AND AN UNLIKELY PROBABILITY OF OCCURRENCE 2 WITH POSSIBLE HARM LISTED AS DELAY IN SURGERY, COMPLETE SURGERY WITH A REPLACEMENT/AN ALTERNATIVE INSTRUMENT. DETERMINED DURING DHR REVIEW.

    Description of Event or Problem · 1

    DURING AN ANKLE DEFORMITY CORRECTION PROCEDURE, THE 7.3MM CANNULATED SCREWS WERE INSERTED BY THE POWER DRIVE, THEN FINAL TIGHTENING WAS TO BE DONE BY HAND. WHEN THE SURGEON STARTED THE FINAL TIGHTENING OF THE SCREWS, THE TABS ON THE END OF THE DRIVER WERE BENT INWARD AND WOULD NOT ALLOW THE DRIVER TO SLIDE OVER THE END OF THE SCREW TO ENGAGE IT FOR FINAL TIGHTENING. THERE WAS NOT ANOTHER SIMILAR SCREWDRIVER AVAILABLE TO USE, SO THE SURGEON USED ANOTHER SCREW OUTSIDE THE PATIENT AND INSERTED IT IN REVERSE IN THE DRIVER TO TRY TO PRY AND BEND THE TABS SLIGHTLY OUTWARD. THE SURGEON WAS THEN ABLE TO SLIDE THE DRIVER OVER THE SCREWS AND FINISH TIGHTENING THEM AS INTENDED AND COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT. NONE OF THE TABS BROKE OFF BUT THE METAL WAS STRESSED BY THE BENDING/ADJUSTING. REBENDING AND ADJUSTING THE TABS ADDED APPROXIMATELY 15 MINUTES TO THE PROCEDURE. PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282415 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES BRANDYWINE 4839668

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR