BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,NAIL

    MDR report key: 8675325 · Received June 6, 2019

    Report

    Report Number
    8030965-2019-64991
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    July 4, 2015
    Report Date
    May 8, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DYNAMIC HIP SCREW (DHS)/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SHARMA, G. ET AL (2015), WHICH AO/OTA 31-A2 PERTROCHANTERIC FRACTURES CAN BE TREATED WITH A DYNAMIC HIP SCREW WITHOUT DEVELOPING A LATERAL WALL FRACTURE? A CT-BASED STUDY , INTERNATIONAL ORTHOPAEDICS (2016) VOLUME 40,PAGES 1009-1017 (INDIA) DOI 10.1007/S00264-015-2835-2. THIS PROSPECTIVE STUDY AIMS TO DETERMINE THE INCIDENCE OF LATERAL WALL FRACTURE IN AO/OTA 31-A2 FRACTURES AFTER DHS IN A PROSPECTIVE COHORT,OBJECTIVELY CALCULATE THE DIMENSIONS OF THE LATERAL FEMORAL WALL USING PREOPERATIVE CT,COMPARE THE DIMENSIONS FOR THE GROUP WITHOUT LATERAL WALL FRACTURE (GROUP I) WITH THE GROUP WITH LATERAL WALL FRACTURE (GROUPII), AND DETERMINE WHETHER A PREDICTION CAN BE MADE BASED ON PREOPERATIVE CT MEASUREMENTS AS TO WHICH AO/OTA 31-A2 FRACTURES HAVE A HIGHER CHANCE OF LATERAL WALL FRACTURE. A LATERAL WALL FRACTURE IS ASSOCIATED WITH LOSS OF REDUCTION OF THE HEAD TO THE SHAFT (COLLAPSE), CUTOUT OF THE IMPLANT, DISPLACEMENT AND SHORTENING OF THE ABDUCTORS, AND POOR ABILITY TO AMBULATE. BETWEEN NOVEMBER 2013 AND MAY 2014, A TOTAL OF 55 PATIENTS, MORE THAN 18 YEARS OF AGE , WITH AN AO 31-A2 PERTROCHANTERIC FRACTURE WERE ENROLLED IN THE STUDY. TWO PATIENTS DIED WITHIN ONE WEEK POSTOPERATIVELY AND TWO PATIENTS WERE LOST TO FOLLOW-UP. FIFTY-ONE (51) PATIENTS WERE THEREFORE INCLUDED IN THE ANALYSIS FIXATION WAS DONE USING A 135° DHS (SYNTHES, GMBH, OBERDORF, SWITZERLAND).THE MEAN DURATION OF FOLLOW UP WAS A MINIMUM OF SIX WEEKS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (HIGHLIGHTED IN TABLE 1) 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 1 MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. 2 PATIENTS DIED WITHIN ONE WEEK POSTOPERATIVELY DURING THEIR STAY IN THE HOSPITAL. THE COMPLAINT INVOLVES 17 REPORTABLE AND 1 NON-REPORTABLE DEVICES. THIS COMPLAINT WILL BE CAPTURED UNDER 2 SEPARATE COMPLAINTS (B)(4) AND (B)(4). THIS REPORT IS FOR ONE (1) MALE PATIENT WITH AN AGE RANGE OF 71.76 YRS (60-85) DEVELOPED FEMORAL WALL FRACTURE. THIS REPORT IS FOR AN UNKNOWN SYNTHES DYNAMIC HIP SCREW (DHS). THIS IS REPORT 6 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468278 APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention