BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5486509 · Received March 8, 2016

    Report

    Report Number
    2520274-2016-11534
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Report Date
    February 9, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN CANNULATED SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. INFORMATION ALREADY CAPTURED ON THE USER FACILITY REPORT: CONCOMITANT PRODUCT: UNKNOWN. IT IS UNKNOWN IF THIS SCREW WAS ALSO IMPLANTED ON (B)(6) 2005 AND EXPLANTED ON (B)(6) 2016. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE UNKNOWN SCREW IS LIKELY PART OF PART FAMILY 207.6XX OR 207.7XX. DUE TO THE DAMAGE, EXACT VERIFICATION IS UNKNOWN. PART FAMILY 207.6XX: 4.0MM CANNULATED SCREW SHORT THREAD (VARYING SIZES) ¿ HWC: SCREW, FIXATION, BONE ¿ K963192. PART FAMILY 207.7XX: 4.0MM CANNULATED SCREW LONG THREAD (VARYING SIZES) ¿ HWC: SCREW, FIXATION, BONE ¿ K963192. PRODUCT INVESTIGATION SUMMARY: ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING, 24MM (PART 202.824 / LOT UNKNOWN) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKEN: POSTOPERATIVELY.¿ THIS SCREW WAS RETURNED WITH A SECOND SCREW, AN UNKNOWN CANNULATED SCREW, THAT HAD NO ALLEGATION OF FAILURE. HOWEVER, UPON PART INVESTIGATION, THE TIP OF THE SCREW WAS BROKEN OFF. THE LOCATION OF THE TIP IS UNKNOWN. THE COMPLAINT CONDITION IS CONFIRMED AS THE SCREWS WERE BOTH RECEIVED WITH THE DISTAL THREADS MISSING. BASED ON THE UNDAMAGED OBTAINABLE FEATURES, THE UNKNOWN CANNULATED SCREW IS CONFORMING TO THE 4.0MM STAINLESS STEEL (SS) CANNULATED SCREW FAMILY; SHORT THREAD (PART NUMBERS 207.610 TO 207.672) OR LONG THREAD (207.716 TO 207.772). THE PART NUMBER COULD NOT BE DEFINITIVELY DETERMINED DUE TO DAMAGE AND THE MISSING PORTION; HOWEVER, THE DOCUMENTS RELATED TO THIS SCREW FAMILY WERE ALSO EVALUATED. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE SCREWS WERE BOTH RECEIVED WITH THE DISTAL THREADS MISSING. THE CANNULATED SCREW WAS RECEIVED WITH A ROUGHLY OBLIQUE FRACTURE AT THE DISTAL TIP. THE THREADS ON THE THREADED PORTION OF THE SHAFT SHOW SIGNIFICANT FLATTENING AND DEFORMATION. THERE IS A DENT NOTED AT THE PROXIMAL TRANSITION FROM THE THREADS TO THE SMOOTH SHAFT. THE PROXIMAL END AND DRIVE RECESS ALSO SHOW NICKS AND WEAR. THUS, WHILE AN ISSUE WAS NOT INITIALLY REPORTED FOR THIS SCREW, IT IS CONFIRMED AS BROKEN. REPLICATION OF THE CONDITION IS NOT APPLICABLE AS THE SCREW IS ALREADY BROKEN AND DEFORMED. THE EXACT MANUFACTURE DATES ARE UNKNOWN; HOWEVER, BASED ON THE IMPLANT DATE OF SEPTEMBER 14, 2005, THEY WERE BOTH MANUFACTURED OVER 10.5 YEARS AGO. THUS, A REVIEW OF THE CURRENT DESIGN DRAWING AND THE DESIGN HISTORY SINCE 2005 FOR THE REPORTED CORTEX SCREW (202_806) AND THE CANNULATED SCREW FAMILY (207_610 AND 207_716) WAS PERFORMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED GIVEN THE UNKNOWN CIRCUMSTANCES AT THE TIME OF THE ISSUE AND OVER THE APPROXIMATELY 10.5 YEARS OF IMPLANT. THE SMALL FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM TECHNIQUE GUIDE WAS REVIEWED AND ADDRESSED RECOMMENDED USAGE. IT WAS NOTED THAT ROUND CUT OUTS ON THE CORTEX SCREW SHOW SIGNS OF IMPACT WITH A DRILL BIT. THIS WOULD NOT BE EXPECTED IF USED AS RECOMMENDED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND A BROKEN CORTEX SCREW. A MALE PATIENT UNDERWENT ON OPEN REDUCTION AND INTERNAL FIXATION OF HIS RIGHT ANKLE ON (B)(6) 2005 WITH A FOUR-HOLE PLATE AND THREE SCREWS. HE SUBSEQUENTLY COMPLAINED OF PAINFUL HARDWARE. A CORTEX SCREW HAD BROKEN INTO TWO PIECES. THE BROKEN SCREW WAS EXPLANTED ON (B)(6) 2016. THERE WAS NO SURGICAL DELAY. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DEVICE WAS RETURNED AND A SECOND SCREW, AN UNKNOWN CANNULATED SCREW, WAS ALSO RETURNED FOR EVALUATION WITH NO ALLEGATION FROM THE COMPLAINANT. HOWEVER, UPON PART INVESTIGATION, THE TIP OF THE SCREW WAS BROKEN OFF. THE LOCATION OF THE TIP IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN CANNULATED SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142605 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1