BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: PFNA

    MDR report key: 15108406 · Received July 26, 2022

    Report

    Report Number
    8030965-2022-05229
    Event Type
    Injury
    Date Received
    July 26, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNKNOWN PFNA SCREW/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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHO, H.M., PARK, J.Y., KWON, K.H., AND LEE, Y. (2021), IS IT ADVANTAGEOUS TO USE THE INTRAOPERATIVE COMPRESSION OPTION OF PROXIMAL FEMORAL NAIL ANTIROTATION IN THE TREATMENT OF OSTEOPOROTIC INTERTROCHANTERIC FRACTURES? A RETROSPECTIVE COMPARATIVE STUDY, ACTA ORTHOPAEDICA ET TRAUMATOLOGICA TURCICA, VOL. 55(4), PAGES 285¿292 (SOUTH KOREA). THE AIM OF THIS STUDY WAS TO RETROSPECTIVELY COMPARE THE RADIOLOGICAL AND CLINICAL RESULTS OF INTERTROCHANTERIC FRACTURES TREATED WITH PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) THAT WERE EITHER INTRAOPERATIVELY COMPRESSED OR NON-COMPRESSED. BETWEEN JANUARY 2015 AND DECEMBER 2017, 94 PATIENTS (64 FEMALE, 30 MALE; MEAN AGE = 77.6 YEARS; AGE RANGE = 68¿81) UNDERWENT INTRAOPERATIVE FRACTURE COMPRESSION (IOFC) (94 HIP JOINTS, GROUP A) AND 88 PATIENTS (64 FEMALE, 24 MALE; MEAN AGE = 77.1 YEARS; AGE RANGE = 67¿80) WHO UNDERWENT POSTOPERATIVE IMPACTION (POI) ALONE (88 HIP JOINTS, GROUP B). ALL OF THESE PATIENT WERE TREATED WITH A PFNA. THE MEAN FOLLOW-UP WAS 38.4 (RANGE = 24-48)MONTHS IN GROUP A AND 36.7 (24-48) MONTHS IN GROUP B. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A: 1 PATIENT REQUIRED REVISION SURGERY FOR HEMATOMA. THE DRAIN WAS WITHDRAWN ON THE DAY OF SURGERY BY A PATIENT WHO DEVELOPED DELIRIUM, AND THE SURGICAL SITE BECAME TIGHT AND TENSIONED. THIS PATIENT HAD A LARGE SUBCUTANEOUS HEMATOMA AT THE SITE OF THE FALL, AND A DRAIN WAS INSERTED. THREE DAYS AFTER THE OPERATION, THE DRAIN WAS REINSERTED AND THE HEMATOMA IMPROVED. GROUP B: 1 PATIENT UNDERWENT A FREE-HANDLE TECHNIQUE INSERTION UNDER FLUOROSCOPY BECAUSE THE TARGET DEVICE BECAME LOOSE DURING SURGERY AND THE DISTAL FIXATION SCREW DIRECTION DID NOT MATCH. 1 PATIENT HAD NONUNION. COMPRESSION OF THE FRACTURE INTERVAL DIDNOT REDUCE UNTIL3MONTHS AFTER THE OPERATION, AND NAIL BREAKAGE OCCURRED IN THE BLADE INSERTION AREA OF THE NAIL AT 5 MONTHS; THUS, THE NAIL WAS CHANGED TO LONG PFNA COMBINED WITH IOFC, AND COMPLETE UNION WAS ACHIEVED 5 MONTHS AFTER REOPERATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES PFNA SCREW. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747730 UNK - SCREWS: PFNA ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention