BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7340465 · Received March 14, 2018

    Report

    Report Number
    8030965-2018-52087
    Event Type
    Injury
    Date Received
    March 14, 2018
    Report Date
    February 13, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN UNK - END CAPS: PFNA/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6) THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: CHOO, S; OH, H-K; KO, H; MIN, D-U; KIM, Y (2017). EFFECTIVENESS OF CONTROLLED TELESCOPING SYSTEM FOR LATERAL HIP PAIN CAUSED BY SLIDING OF BLADE FOLLOWING INTRAMEDULLARY NAILING OF TROCHANTERIC FRACTURE. INJURY, INT. J. CARE INJURED, 48, PP.2201-2206. A RETROSPECTIVE COHORT STUDY WAS PERFORMED TO COMPARE THE CONTROLLED TELESCOPING SYSTEM WITH A LAG SCREW AT 125 (COMPRESSION HIP NAIL; CHN) WITH THE CONVENTIONAL SLIDING SYSTEM WITH A BLADE ANGLE OF 125 (PROXIMAL FEMORAL NAIL ANTIROTATION; PFNA) FOR TROCHANTERIC FRACTURES. 74 CASES IN THE PFNA GROUP AND 77 CASES IN THE CHN GROUP WERE INCLUDED FROM TWO UNIVERSITY HOSPITALS IN THIS STUDY FROM NOVEMBER 2012 TO JANUARY 2014. LATERAL HIP PAIN WAS EVALUATED AND OPERATION TIME AND BLOOD LOSS DURING THE SURGERY WERE MEASURED. THE FRACTURE CLASSIFICATION WAS EVALUATED. THE QUALITY OF POSTOPERATIVE REDUCTION AND OTHER COMPLICATIONS AFTER SURGERY WERE ALSO EVALUATED AND TIP-APEX DISTANCE (TAD), TELESCOPING AND LATERAL PROTRUSION OF THE BLADE AND LAG SCREW WERE MEASURED. THE INCLUSION CRITERIA INCLUDED 1) TROCHANTERIC FRACTURE, 2) NO OTHER FRACTURES ON THE LOWER EXTREMITIES, CONTRALATERAL HIP OR PELVIS, 3) TREATMENT WITH EITHER PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA; SYNTHES,(B)(4)) OR COMPRESSION HIP NAIL ((B)(4)), 4) CONFIRMATION OF UNION WITH MINIMUM 12 MONTH FOLLOW-UP AFTER SURGERY AND 5) NO OTHER COMPLICATIONS EXCEPT LATERAL HIP PAIN. THERE WERE 53 MEN AND 98 WOMEN WITH A MEAN AGE OF 76.5 YEARS AT OPERATION (RANGE, 31¿96 YEARS). THE RIGHT SIDE WAS AFFECTED IN 64 PATIENTS AND THE LEFT SIDE IN 87. THE MEAN AMOUNT OF BLOOD LOSS IN ALL PATIENTS WAS 123.0 G (RANGE, 10¿680 G), MEAN OPERATION TIME WAS 47.0 MIN (RANGE, 20¿95 MIN), THE MEAN TELESCOPING WAS 14.86 MM (RANGE 4.25¿32.12 MM), MEAN LENGTH OF LATERAL PROTRUSION WAS 6.38 MM (RANGE, 0¿21.91 MM) AND MEAN TAD WAS 20.20 MM (RANGE 7.85¿40.30 MM). FORTY PATIENTS OUT OF 151 (26.5%) COMPLAINED OF LATERAL HIP PAIN AFTER SURGERY. EIGHTY PATIENTS (53.0%) SHOWED GOOD REDUCTION QUALITY, 60 (39.8%) HAD ACCEPTABLE QUALITY, AND 11 (7.3%) HAD POOR REDUCTION QUALITY. OF THE 11 PATIENTS, 7 PATIENTS WERE IN THE PFNA GROUP. SIXTY-EIGHT PATIENTS HAD A1 FRACTURE, 68 HAD A2 FRACTURE, AND 15 HAD A3 FRACTURE PATTERNS. THE MEAN AGE WAS 78.5 YEARS IN THE PFNA GROUP. THE MEAN TELESCOPING WAS 19.2 MM IN THE PFNA GROUP. THE MEAN LENGTH OF LATERAL PROTRUSION WAS 10.5 MM IN THE PFNA GROUP. TWENTY-EIGHT PATIENTS IN THE PFNA GROUP (37.8%) COMPLAINED OF LATERAL HIP PAIN AFTER SURGERY. THE DEGREE OF LATERAL PROTRUSION WAS MAINLY RELATED TO LATERAL HIP PAIN. FORTY-SIX PATIENTS IN THE NO PAIN GROUP (41.4%) WERE TREATED WITH SURGERY USING PFNA AND SIXTY-FIVE PATIENTS IN THE NO PAIN GROUP (58.6%) WERE TREATED WITH SURGERY USING CHN, WHEREAS TWENTY-EIGHT PATIENTS IN THE PAIN GROUP (70.0%) WERE TREATED WITH SURGERY USING PFNA AND TWELVE PATIENTS IN THE PAIN GROUP (30.0%) WERE TREATED WITH SURGERY USING CHN (P = 0.002). 23 PATIENTS (57.5%) WERE TREATED WITH MEDICATION SUCH AS NSAIDS FOR LATERAL HIP PAIN, 9 PATIENTS (22.5%) WERE TREATED WITH STEROID INJECTION AT THE PAIN SITE, 7 PATIENTS (17.5%) REQUIRED SIMPLE OBSERVATION AND 1 PATIENT (2.5%) RECEIVED A LAG SCREW CHANGE FOR LATERAL MIGRATION OF THE OUTER BARREL OF CHN AT THE 6 MONTH FOLLOW UP FROM INITIAL SURGERY. A RADIOGRAPH SHOWED: LATERAL PROTRUSION (LP): THE DISTANCE FROM THE LATERAL CORTEX OF THE FEMUR TO THE BLADE OR LAG SCREW END ALONG THE SUPERIOR BORDER; INITIAL RADIOGRAPH, IMMEDIATE POSTOPERATIVE RADIOGRAPH AND 1 YEAR FOLLOW UP RADIOGRAPH AFTER SURGERY WITH PFNA ( NO PATIENT IDENTIFIER). FORTY PATIENTS OUT OF A TOTAL OF 151 PATIENTS IN THIS STUDY (26.5%) HAD LATERAL HIP PAIN AFTER SURGERY AND AS MANY AS TWENTY-EIGHT PATIENTS IN THE PFNA GROUP COMPLAINED OF LATERAL HIP PAIN. THOSE PATIENTS WHO HAD LATERAL HIP PAIN EXPERIENCED IT WHEN THEY WALKED OR ASSUMED THE DECUBITUS POSITION ON THE INVOLVED LIMB. THIS IS REPORT 3 OF 4 FOR PC-000131748. THE REPORT IS FOR AN UNKNOWN (SCREW). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR TWENTY - EIGHT PFNA CONSTRUCTS CONSISTING OF A NAIL, BLADE, SCREW AND END CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181746 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention