BEUDAMED
    FDA Adverse Event Injury Summary report: N

    95 DEG DCS® PLATE 8 HOLES/146MM

    MDR report key: 6447486 · Received March 30, 2017

    Report

    Report Number
    2520274-2017-11128
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    March 11, 2017
    Report Date
    March 13, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    KTT
    PMA / PMN Number
    K791619
    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 DEVICE PRODUCT CODE IS HRS. (B)(4). THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. (B)(4). 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART # 281.980, LOT # 8290948: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 14 FEBRUARY 2013. NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 INVESTIGATION WAS CONDUCTED ON: 1 X 281.980 / LOT NO.: 8290948 / PLATE DCS 95° 8HO L146 SST / BROKEN . RECEIVED CONDITION: DCS PLATE: THE PLATE IS BROKEN IN HALF AT THE 2ND SCREW ROUND-BORE. THERE ARE POST-MANUFACTURING CAUSED VISIBLE MARKS AND SCRATCHES IN SOME AREAS. DIMENSION: DCS PLATE: THE DIMENSIONS OF THE BROKEN DCS 95° 8HO L146 SST STAINLESS STEEL PLATE WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE VALID TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. MATERIAL: DCS PLATE: THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARD OF STAINLESS STEEL 316L- 1.4441 / ISO 5832-1. CONCLUSION: THE DHR REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE LOT IN QUESTION WAS MANUFACTURED WITH A LOT SIZE OF (B)(4) PIECES IN FEBRUARY 2013 AND WE ARE NOT AWARE OF ANY QUALITY ISSUES OR FAILURES CAUSED BY A FAULTY PRODUCT. TO DATE WE ARE NOT AWARE OF ANY OTHER SIMILAR COMPLAINTS RELATED TO THE ARTICLE AND LOT NUMBER IN QUESTION. THE FRACTURE SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. NEITHER A MANUFACTURING NOR A MATERIAL RELATED FAULT WAS DETECTED. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, OVERLOADING OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO THE FAILURE OF THE IMPLANT. THE DYNAMIC HIP PLATING IMPLANTS - CORE DOSSIER DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT, (B)(4), WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HARM OF THIS COMPLAINT CONDITION. ALL RECEIVED CONCOMITANT PARTS LISTED IN THE COMPLAINT DESCRIPTION ARE INTACT AND BESIDE SOME WEAR UNDAMAGED: 1X 280.750 HS/DCS-SCREW Ø12.5 L75 SST, 7X 214.0XX CORTEX SCREWS Ø4.5 / VARIOUS LENGTHS, 1X 280.990 DHS/DCS-COMPRESSION SCREW L36 SST. 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 EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DYNAMIC CONDYLAR SYSTEM (DCS) PLATE BROKE ON (B)(6) 2017 TWO DAYS AFTER IMPLANTATION ON (B)(6) 2017. REVISION SURGERY EXPECTED BE PERFORMED BUT THE DATE HAS NOT BEEN REPORTED TO THE MANUFACTURER. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE BREAKAGE OCCURRED IN THE SCREW HOLE. CONCOMITANT MEDICAL PRODUCTS: HS/DCS-SCR Ø12.5 L75 SST (PART# 280.750 / LOT# 9807767 / QUANTITY 1); CORTSCR Ø4.5 L60 SST (PART# 214.060/ LOT# 9130379 / QUANTITY 1); CORTSCR Ø4.5 L38 SST (PART# 214.038 / LOT# 9579291 / QUANTITY 1); CORTSCR Ø4.5 L36 SST (PART# 214.036 / LOT# 9578884 / QUANTITY 1); CORTSCR Ø4.5 L52 SST (PART# 214.052 / LOT# 9570670 / QUANTITY 1); CORTSCR Ø4.5 L40 SST (PART# 214.040 / LOT# 9502086 / QUANTITY 1); DHS/DCS-COMPRSCR L36 SST (PART# 280.990/ LOT# 9754973 / QUANTITY 1); CORTSCR Ø4.5 L40 SST (PART# 214.040/ LOT# 8542789 / QUANTITY 1); CORTSCR Ø4.5 L42 SST (PART# 214.042/ LOT# 8911809 / QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227257 95 DEG DCS® PLATE 8 HOLES/146MM APPLIANCE, FIXATION, NAIL KTT SYNTHES GRENCHEN 8290948

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention