BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM-STERILE

    MDR report key: 4156488 · Received October 9, 2014

    Report

    Report Number
    3009450863-2014-10037
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE SUBJECT DEVICE (LAG SCREW) WAS RECEIVED WITH THE END AND THE SLOT BADLY DAMAGED. THE REMAINDER OF THE BROKEN CONNECTION SCREW IS STUCK IN THE LAG SCREW. THE SLOTTED END OF THE LAG SCREW IS IN A VERY BAD CONDITION. THERE ARE HEAVY STRESS MARKS ON THE OUTER SIDE AND THE SLOT IS PARTIALLY DEFORMED. IN ADDITION THE REMAINDER OF THE BROKEN CONNECTION SCREW IS STUCK IN THE LAG SCREW. DUE TO THESE DAMAGES THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. THE PASSIVATED LAYER IS WORN OUT AT ALL DAMAGES, WHICH INDICATES THAT THEY WERE CAUSED POST-MANUFACTURING, MOST PROBABLY DURING THE EXTRACTION OF THE SCREW AFTER THE CONNECTION SCREW BROKE. THERE IS NO ALLEGATION OF COMPLAINT SUCH AS, EXCESSIVE INSERTION FORCE NEEDED, AGAINST THE LAG SCREW IN THE COMPLAINT DESCRIPTION. BASED ON THE COMPLAINT DESCRIPTION, WE ASSUME THAT THE LAG SCREW DID NOT CONTRIBUTE TO THE BREAKAGE OF THE CONNECTION SCREW. THEREFORE, THIS TASK IS DEEMED UNCONFIRMED IN RELATION WITH THE LAG SCREW. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN JANUARY 2014, ALL PARTS ARE SOLD AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART AND LOT NUMBER, WHICH ALSO SPEAKS AGAINST AN ISSUE WITH THE LAG SCREW. 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

    PT'S AGE: AGE REPORTED AS 70'S ¿ 80. IMPLANT EXPLANT DATES:: DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(4). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE INSTRUMENTS WERE RECEIVED VISUALLY CLEAN BUT BROKEN. ACCORDING TO THE COMPLAINT REPORT THE INSERTION OF THE DYNAMIC HIP SCREW (DHS) WAS PERFORMED WITHOUT THE CENTERING SLEEVE (ARTICLE (B)(4)) WHEREAS THE SURGICAL TECHNIQUE GUIDE INCLUDES THE CENTERING SLEEVE. THE CENTERING SLEEVE PROVIDES MORE STABILITY BETWEEN THE WRENCH AND THE DHS SCREW AND COULD REDUCE THE RISK OF BREAKAGE OF THE CONNECTION SCREW. NEVERTHELESS, BASED ON THE PROVIDED INFORMATION, THE MATERIAL AND THE LOW OCCURRENCE RATE A DESIGN RELATED ISSUE CAN BE EXCLUDED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS AN UNDISPLACED INTRACAPSULAR FRACTURE IN AN ELDERLY PATIENT LATE 70'S - 80. INSERTED THE DYNAMIC HIP SCREW GUIDEWIRE AND THE ANTIROTATION GUIDEWIRE INTO FEMORAL HEAD. MEASURED THEN CHOSE THE RIGHT LENGTH SCREW. NO TAPPING WAS CONDUCTED AS THE PATIENT HAD SOFT BONE. THE SCREW WAS INSERTED INTO THE FEMORAL HEAD WITHOUT THE CENTERING GUIDE OR PLATE DURING THE ONE-STEP INSERTION METHOD. A CLICK WAS THEN HEARD DURING THE END OF SCREW INSERTION. THE SURGEON THOUGHT IT WAS THE FEMORAL NECK BREAKING BUT REALIZED AT THIS POINT THAT THE GUIDEWIRE HAD BENT AND THE HEAD WAS ROTATED SO HE HAD LOST HIS REDUCTION. HE THEN REALIZED THAT AS HE TURNED HIS T-HANDLE, THE SCREW WAS NEITHER ADVANCING NOR REVERSING. AND THEN HE TRIED TO UNDO THE SCREW WITH THE HANDLE AND DISCOVERED THE END OF THE CONNECTION SCREW TIP WAS BROKEN. THE PATIENT THEN HAD TO HAVE A HEMI ARTHROPLASTY INSTEAD WHICH CAUSED ADDITIONAL TRAUMA AND COMPLICATION TO THE PATIENT. THE WELD ON THE T-HANDLE WAS BROKEN DURING THE ATTEMPT TO REVERSE THE SCREW. THE HANDLE WAS ABLE TO BE RECONNECTED AND PUT BACK INTO THE SET. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634356 DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM-STERILE APPLIANCE, FIXATION, NAIL KTT SYNTHES BALSTHAL 8819218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention