BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø12 LONG LE 125° L380 TAN

    MDR report key: 6099105 · Received November 14, 2016

    Report

    Report Number
    9612488-2016-10459
    Event Type
    Injury
    Date Received
    November 14, 2016
    Report Date
    October 22, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: WE HAVE FORWARDED THE RECEIVED NAIL (04.027.249S / 9943331) TO THE RESPONSIBLE MANUFACTURING SITE FOR INVESTIGATION, HERE IS THE STATEMENT: UPON VISUAL INSPECTION, THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER MARKING WAS READABLE. THE NAIL WAS CROSS BROKEN IN THE POSITION OF THE CITRUS HOLE. TRACES OF USE WERE VISIBLE AROUND THE CITRUS HOLE. SLIGHTLY TRACES OF USE WERE VISIBLE ON THE OTHER PART OF THE NAIL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, (B)(4) PARTS WERE DELIVERED TO THE WAREHOUSE, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE ARTICLE WAS MANUFACTURED IN MAY 2016. NO NCRS WERE MARKED IN THE DHR DURING PRODUCTION. MOREOVER A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS, THAT THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS ARTICLE AND LOT NUMBER. THE OUTER DIAMETER WHICH IS RELEVANT FOR THE FUNCTION OF THE PRODUCT WAS MEASURED, AND FULFILLS THE SPECIFICATIONS. CITRUS HOLE COULD NOT BE MEASURED IN REASON OF BREAKAGE. THE ACCORDING INSPECTION SHEET SHOWS A 100% APPROVAL OF THE DIMENSION OF THE CITRUS HOLE. THE RAW MATERIAL CERTIFICATES WERE CHECKED AND IT WAS FOUND THAT ALL USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED, BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. THERE IS NO PARTICULARIZE INFORMATION WHAT'S HAPPENED TO THIS ARTICLE BY CUSTOMER, UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE. FURTHERMORE, WE HAVE ALSO RECEIVED TWO INTACT PARTS (1X BLADE 04.027.035S / L021208 AND 1X SCREW 459.500 / 5935376): AS THOSE PARTS ARE NOT RESPONSIBLE FOR THE BREAKAGE OF THE NAIL, NO FURTHER INVESTIGATION WILL BE DONE. DEVICE 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.

    Additional Manufacturer Narrative · 1

    PATIENT ID, DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. (B)(4). (B)(6). (B)(4). THE 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE RECORDS REVIEW WAS COMPLETED FOR PART # 04.027.249S, LOT # 9943331. MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: MAY 18, 2016, EXPIRY DATE: MAY 01, 2026. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE 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 · 1

    DEVICE REPORT FOR SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT SECOND (2ND) REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2016, DUE TO BREAKAGE OF PROXIMAL FEMORAL NAIL-ANTIROTATION (PFNA) NAIL. THE PATIENT INITIALLY HAD THE PFNA SYSTEM IMPLANTED ON AN UNKNOWN DATE APPROXIMATELY TWO (2) MONTHS PRIOR TO THE FIRST (1ST) REVISION SURGERY TO TREAT A SUB TROCHANTERIC FRACTURE. TWO MONTHS (DATE ALSO UNKNOWN) LATER PATIENT HAS PRESENTED WITH THE NAIL BROKEN AT THE POINT WHERE THE BLADE CROSSES THROUGH. THE SURGEON ACKNOWLEDGED THAT THERE WAS QUITE A LARGE BONE VOID WHICH WAS LEFT. DURING THE REVISION SURGERY ON (B)(6) 2016, THE ORIGINAL NAIL WAS REMOVED AND THE PATIENT WAS REVISED WITH ANOTHER PFNA NAIL. FIRST REVISION SURGERY IS CAPTURE UNDER (B)(4). THIS REPORT IS FOR ONE (1) PFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751629 PFNA Ø12 LONG LE 125° L380 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 9943331

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention