BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II Ø10 SM 130° L200 TAN

    MDR report key: 7928089 · Received October 2, 2018

    Report

    Report Number
    8030965-2018-56928
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    September 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819837386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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. ADDED CONCOMITANT DEVICE. LOT NUMBER; EXPIRATION DATE A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 472.115S LOT: 8161347 MANUFACTURING SITE: BETTLACH RELEASE TO WAREHOUSE DATE: 21.NOV.2012 EXPIRY DATE: 01.NOV.2022 THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 12 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING SPECIFICATION.REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL SYNTHES BAG. THE LASER MARKING WAS READABLE. TRACES OF USE WERE VISIBLE AND THE NAIL IS BROKEN AT THE CITRUS SHAPE. DOCUMENT/SPECIFICATION REVIEW: A DHR REVIEW WAS PERFORMED FOR THE AFFECTED WORK ORDER. DURING THE REVIEW, NO NCS OR DCOS WERE FOUND. THEREFORE, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED WHICH COULD LEAD TO THE COMPLAINT DESCRIPTION. DIMENSIONAL INSPECTION: THE OUTER (16.5 MM) AND INNER DIAMETER (4.4 MM) WERE MEASURED AND HAVE FULFILLED THE SPECIFICATIONS. IN ADDITION, THE ¿CITRUS SHAPE¿ AND THE ¿RUN-OUT 1MM TO A¿ (ALSO CLASSIFIED AS CTQ -CRITICAL TO QUALITY- ACCORDING TO THE PQP) HAVE BEEN IDENTIFIED AS RELEVANT FEATURES HOWEVER, THESE FEATURES COULD NOT BE MEASURED (AS PERFORMED DURING THE MANUFACTURING PROCESS) BECAUSE THE NAIL HAS BEEN BROKEN. BESIDES, DURING THE MANUFACTURING PROCESS THESE FEATURES WERE INSPECTED THROUGH THE INSPECTION SHEET (PART OF THE ATTACHED WORK ORDER) AND THE WHOLE LOT HAS PASSED ITS SPECIFICATIONS. THEREFORE, ANY MANUFACTURING ISSUE HAS BEEN EXCLUDED. MATERIAL OR HARDNESS REVIEW: THE RAW MATERIAL CERTIFICATE WAS CHECKED AND THE USED RAW MATERIAL HAS FULFILLED THE SPECIFICATIONS. SUMMARY: BASED ON THE INVESTIGATION RESULT THIS COMPLAINT IS RATED AS CONFIRMED SINCE THE NAIL IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW THE RELEVANT FEATURES WERE MEASURED AND HAVE FULFILLED ITS SPECIFICATIONS AS WELL AS IN THE MANUFACTURING DOCUMENTATION NO ISSUE WAS IDENTIFIED. DUE TO NO MANUFACTURING ISSUE WAS IDENTIFIED AND THIS COMPLAINT IS NOT VALID, THEREFORE NO ADDITIONAL ACTIONS ARE REQUIRED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    CONCOMITANT DEVICE REPORTED: BOLT Ø4.9 SELF-TAP L40 TAN GREEN (PART # 459.400, LOT # 5920877, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DATE OF POSTOPERATIVE PFNA NAIL BREAKAGE IS UNKNOWN. DEVICE WAS IMPLANTED IN 2013; EXACT DATE IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 DUE TO BROKEN PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL AND PFNA BLADE. PATIENT HAD AN ORIGINAL IMPLANTATION IN 2013. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. IT WAS ALSO REPORTED THAT AT PRESENT IT IS NOT POSSIBLE TO GET THE SERIAL NUMBER AND LOT NUMBER AS DEVICES ARE RUSTY. THIS REPORT IS FOR ONE (1) PFNA NAIL THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769002 PFNA-II Ø10 SM 130° L200 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 8161347 07611819837386

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention