BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: NAIL DISTAL LOCKING

    MDR report key: 17254856 · Received July 5, 2023

    Report

    Report Number
    8030965-2023-08307
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: ARJUN MINHAS, MD MS., ET AL (2023), BACKOUT OF DISTAL INTERLOCKING SCREWS AFTER RETROGRADE FEMORAL NAILING WITH A NOVEL DEVICE ¿ A CASE SERIES, JAIDS JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROME PUBLISH AHEAD OF PRINT DOI:10.1097/BOT.0000000000002646, (USA). THIS RETROSPECTIVE CASE SERIES AIMS TO REPORT UPON A SERIES OF PATIENTS WHO HAVE EXPERIENCED THE BACKOUT OF DISTAL INTERLOCKING SCREWS AFTER RETROGRADE FEMORAL NAILING WITH DEPUY SYNTHES RFN-ADVANCED RETROGRADE FEMORAL NAILING SYSTEM (DEPUY SYNTHES, RAYNHAM, MA, USA). TWENTY-SEVEN SKELETALLY-MATURE PATIENTS WITH FEMORAL SHAFT OR DISTAL FEMUR FRACTURES WHO UNDERWENT OPERATIVE FIXATION WITH THE DEPUY SYNTHES RFN-ADVANCED RETROGRADE FEMORAL NAILING SYSTEM (RFNA) WITH 8 PATIENTS SUBSEQUENTLY EXPERIENCING BACKOUT OF DISTAL INTERLOCKING SCREWS. PATIENTS WHO EXPERIENCED SCREW BACKOUT HAD AN AVERAGE AGE OF 64.5 YEARS )RANGE: 54-84) WITH AN AVERAGE BMI OF 36.6KGM2 (RANGE: 18.9-70.1). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: CASE 1, 58 FEMALE HAD OBLIQUE LATERAL, LATERAL WASHER AND OBLIQUE MEDIAL INTERLOCKING SCREW BACKOUT. PATIENT COMPLAINED OF IMPLANT PROMINENCE AND PAIN ALONG THE MEDIAL OR LATERAL ASPECT OF THE KNEE. CASE 2, 79 FEMALE HAD OBLIQUE MEDIAL INTERLOCKING SCREW BACKOUT. PATIENT COMPLAINED OF IMPLANT PROMINENCE AND PAIN ALONG THE MEDIAL OR LATERAL ASPECT OF THE KNEE. CASE 3, 79 MALE HAD OBLIQUE MEDIAL INTERLOCKING SCREW BACKOUT. PATIENT COMPLAINED OF IMPLANT PROMINENCE AND PAIN ALONG THE MEDIAL OR LATERAL ASPECT OF THE KNEE. CASE 4, 58 FEMALE HAD OBLIQUE MEDIAL INTERLOCKING SCREW BACKOUT. PATIENT COMPLAINED OF IMPLANT PROMINENCE AND PAIN ALONG THE MEDIAL OR LATERAL ASPECT OF THE KNEE. CASE 5, 84 FEMALE HAD OBLIQUE LATERAL INTERLOCKING SCREW BACKOUT. PATIENT COMPLAINED OF IMPLANT PROMINENCE AND PAIN ALONG THE MEDIAL OR LATERAL ASPECT OF THE KNEE. CASE 6, 55 FEMALE HAD ORTHOGONAL MEDIAL, ORTHOGONAL LATERAL AND OBLIQUE LATERAL INTERLOCKING SCREW BACKOUT. PATIENT COMPLAINED OF IMPLANT PROMINENCE AND PAIN ALONG THE MEDIAL OR LATERAL ASPECT OF THE KNEE. CASE 7, 50 MALE HAD ORTHOGONAL LATERAL INTERLOCKING SCREW BACKOUT. PATIENT COMPLAINED OF IMPLANT PROMINENCE AND PAIN ALONG THE MEDIAL OR LATERAL ASPECT OF THE KNEE. CASE 8, 54 FEMALE HAD ORTHOGONAL LATERAL AND OBLIQUE LATERAL INTERLOCKING SCREW BACKOUT. PATIENT COMPLAINED OF IMPLANT PROMINENCE AND PAIN ALONG THE MEDIAL OR LATERAL ASPECT OF THE KNEE. AN UNKNOWN PATIENT HAD NO SCREWS WERE NOTED TO BACK OUT, ALTHOUGH MOST RECENT RADIOGRAPHS DEMONSTRATE A NON-UNION OF THE METADIAPHYSIS CONFIRMED BY RECENT CT SCAN. THIS REPORT IS FOR AN UNKNOWN SYNTHES RETROGRADE FEMORAL NAIL, UNKNOWN SYNTHES LOCKING SCREWS AND UNKNOWN SYNTHES WASHERS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR ONE (1) UNK - SCREWS: NAIL DISTAL LOCK. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418669 UNK - SCREWS: NAIL DISTAL LOCKING SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention