BEUDAMED
    FDA Adverse Event Injury Summary report: N

    135 DEG DHS PLATE-STD BARREL 2 HOLES/46MM-STERILE

    MDR report key: 4415275 · Received January 13, 2015

    Report

    Report Number
    3003506883-2015-10017
    Event Type
    Injury
    Date Received
    January 13, 2015
    Date of Event
    December 21, 2014
    Report Date
    December 21, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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 INVESTIGATION WAS COMPLETED: ONE 135 DEGREE DHS PLATE, PART NUMBER 381.102S, AND ONE DHS/DCS GUIDE SHAFT, PART NUMBER 338.21 WAS RECEIVED, ONE DHS/DCS LAG SCREW, PART NUMBER 380.850S, WAS RECEIVED AND ONE DHS/DCS COUPLING SCREW, PART NUMBER 338.20, WAS RECEIVED. THE RETURNED DHS PLATE, LOT NUMBER 7802989, WAS MANUFACTURED OCT, 2014. IT WAS RECEIVED WITH A DENT DIRECTLY BELOW THE LAG SCREW HOLE ON THE LATERAL SURFACE OF THE PLATE. THE FLATS ON THE LAG SCREW BARREL, WHICH MATE WITH THE LAG SCREW, SHOW SLIGHT DEFORMATION. THE RETURNED DHS/DCS COUPLING SCREW, LOT NUMBER 1049, WAS MANUFACTURED MARCH, 1993. IT WAS RECEIVED IN GOOD CONDITION SHOWING ONLY WORN EDGES. THE RETURNED DHS/DCS GUIDE SHAFT, LOT NUMBER 1012, WAS MANUFACTURED JUNE, 1989. IT WAS RECEIVED WITH NICKS AND SCRATCHES OVER THE SURFACE OF THE DEVICE. THE PRONGS THAT COUPLE WITH THE LAG SCREW SHOW FLATTENING AND NICKS. THE BALANCE OF EACH RETURNED PART IS IN GOOD CONDITION. WHEN ASSEMBLED THE PLATE WILL NOT SLIDE OVER THE POINT WHERE THE GUIDE SHAFT CONNECTS TO THE LAG SCREW. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND COULD BE REPLICATED. A REVIEW OF THE DESIGN DRAWINGS FOR THE PLATE, THE LAG SCREW, THE COUPLING SCREW, AND THE GUIDE SHAFT WAS PERFORMED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED AND THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE. THEREFORE, THE COMPLAINT CONDITION WAS DETERMINED TO NOT BE THE RESULT OF A DESIGN DEFICIENCY. PER THE TECHNIQUE GUIDE, THE RETURNED IMPLANTS ARE PART OF THE DYNAMIC HIP SCREW (DHS) SYSTEM AND THE DEVICES ARE USED SPECIFICALLY FOR INSERTION OF THE LAG SCREW FOR A DHS OR A DYNAMIC CONDYLAR SCREW (DCS). ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED WITHOUT ADDITIONAL INFORMATION REGARDING THE USER TECHNIQUE AND THE CONDITIONS AT THE TIME OF THE DAMAGE, THE RETURNED CONDITION IS CONSISTENT WITH EXCESSIVE FORCE PRIOR TO ACHIEVING PROPER ALIGNMENT AND/OR THE EXTENSIVE WEAR OF THE DEVICES OVER AN EXTENDED LIFETIME. THE GUIDE SHAFT IS OVER 25 YEARS OLD AND THE COUPLING SCREW IS OVER 22 YEARS OLD. 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

    LOT 7802989 EXPIRES IN SEPTEMBER 2023. DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: DATE OF MANUFACTURE: OCTOBER 17, 2014 - EXPIRY DATE: SEPTEMBER 2023 A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS LOT 7802989 OF 135 DEG DHS PLATE-STD BARREL 2 HOLES 46MM STERILE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD DETERMINED THE RAW MATERIAL LOT 6908471 MET ALL SPECIFICATIONS. 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

    IT WAS REPORTED THAT, DURING A DYNAMIC HIP SCREW (DHS) PROCEDURE ON A NON-DISPLACED INTERTROCHANTERIC FRACTURE, THE DEVICES WOULD NOT ALIGN PROPERLY. THE CONNECTING SCREW WOULD NOT KEY IN AS THE SURGEON PLACED THE LAG SCREW INTO THE FEMORAL HEAD AND SLID THE PLATE OVER THE CONNECTING SCREW. THE SURGEON USED AN IMPACTOR AND A MALLET IN AN ATTEMPT TO SEAT THE SCREW ONTO THE PLATE. THE LAG SCREW LOST FIXATION AT THE FEMORAL HEAD. AN X-RAY DETERMINED THAT THE LAG SCREW HAD MOVED AND THAT 6 INCHES OF BONE WAS LOST. AS SUCH, THE DHS WAS ABANDONED AND THE SURGERY WAS CONVERTED TO A TROCHANTERIC FIXATION NAIL PROCEDURE. THE SURGERY, DELAYED BY 30 MINUTES, WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30664 135 DEG DHS PLATE-STD BARREL 2 HOLES/46MM-STERILE APPLIANCE, FIXATION, NAIL KTT SYNTHES ELMIRA 7802989

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention