BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE

    MDR report key: 19994634 · Received August 15, 2024

    Report

    Report Number
    8030965-2024-09996
    Event Type
    Injury
    Date Received
    August 15, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. H11 ADDITIONAL NARRATIVE: B5: THE LITERATURE SOURCE CAN BE ACCESSED BY COPYING AND PASTING THE FOLLOWING DOI LINK INTO A BROWSER: DOI: 10.1007/S00402-023-05176-3. D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN NAIL HEAD ELEMENTS: PFNA-II BLADE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHO YH, KIM S, KOO J, BYUN SE. FAILURE AFTER INTRAMEDULLARY NAILING FOR GERIATRIC TROCHANTERIC FRACTURE: DOES QUALITY OF FRACTURE REDUCTION ON THE AP AND LATERAL PLANES SHOW THE SAME RESULTS? ARCH ORTHOP TRAUMA SURG. 2024 MAR;144(3):1233-1241. DOI: 10.1007/S00402-023-05176-3. EPUB 2024 JAN 2. PMID: 38167750. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO INVESTIGATE THE FAILURE OF TROCHANTERIC FRACTURE FXATION ACCORDING TO THE QUALITY OF FRACTURE REDUCTION ON THE ANTEROPOSTERIOR (AP) AND LATERAL VIEWS. BETWEEN 2016 AND 2020, A TOTAL OF 492 PATIENTS (152 MALE AND 340 FEMALE) WITH FEMORAL TROCHANTERIC FRACTURE WERE INCLUDED IN THE STUDY. THE AVERAGE AGE AT THE TIME OF SURGERY WAS 79.1±8.1 YEARS (RANGE 60.0¿99.0 YEARS). A PROXIMAL FEMORAL NAIL ANTIROTATION II (PFNA II; SYNTHES, OBERDORF, SWITZERLAND) IMPLANT WITH A LENGTH OF 200 MM, CAPUTCOLLUM-DIAPHYSEAL (CCD) ANGLE OF 125°, AND SPIRAL BLADE WAS USED FOR ALL CASES. THE AVERAGE FOLLOW-UP PERIOD WAS 14.3± 9.9 MONTHS (RANGE 6¿54 MONTHS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PFNA II ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: PFNA-II (QTY 15) 15 PATIENTS DID NOT ACHIEVED BONE UNION; INTERVENTION NOT PROVIDED ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE (QTY 8) 3 PATIENTS HAD CUT-THROUGH; TREATMENT NOT SPECIFIED BUT ARTICLE STATED THAT "CONVERSION TO HIP ARTHROPLASTY WAS PERFORMED IN NINE PATIENTS, AND OSTEOSYNTHESIS WAS PERFORMED IN FOUR PATIENTS. TWO PATIENTS REFUSED FURTHER SURGICAL MANAGEMENT DUE TO GENERAL MEDICAL CONDITIONS." 5 PATIENTS HAD CUT-OUT; TREATMENT NOT SPECIFIED BUT ARTICLE STATED THAT "CONVERSION TO HIP ARTHROPLASTY WAS PERFORMED IN NINE PATIENTS, AND OSTEOSYNTHESIS WAS PERFORMED IN FOUR PATIENTS. TWO PATIENTS REFUSED FURTHER SURGICAL MANAGEMENT DUE TO GENERAL MEDICAL CONDITIONS." ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAILS: PFNA-II (QTY 7) 7 PATIENTS HAD NAIL BREAKAGE; TREATMENT NOT SPECIFIED BUT ARTICLE STATED THAT "CONVERSION TO HIP ARTHROPLASTY WAS PERFORMED IN NINE PATIENTS, AND OSTEOSYNTHESIS WAS PERFORMED IN FOUR PATIENTS. TWO PATIENTS REFUSED FURTHER SURGICAL MANAGEMENT DUE TO GENERAL MEDICAL CONDITIONS." ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAILS: PFNA-II (QTY 1) A 78-YEAR-OLD WOMAN HAD A FAILURE AFTER NAILING (THE NAIL WAS BROKEN). THE FRACTURE WAS HEALED AFTER REVISIONAL OSTEOSYNTHESIS USING THE BLADE PLATE. THIS REPORT INVOLVES AN UNKNOWN NAIL HEAD ELEMENTS: PFNA-II BLADE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683233 UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention