BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFN Ø10 CANN R 130° L340 SST

    MDR report key: 7491180 · Received May 7, 2018

    Report

    Report Number
    8030965-2018-53570
    Event Type
    Injury
    Date Received
    May 7, 2018
    Report Date
    April 17, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819089549
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NUMBER: 273.345, SYNTHES LOT NUMBER: 9669817: RELEASE TO WAREHOUSE DATE: 07 DEC 2015, MANUFACTURING SITE: BETTLACH: THE RAW MATERIAL (17758) WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. NR WAS GENERATED DURING PRODUCTION DUE TO A SMOKE ALERT IN THE NAIL DEPARTMENT IN BETTLACH ON (B)(6) 2015. THIS NCR DOCUMENTED A CLEANLINESS TESTING ACCORDING VALIDATED PROCEDURE. THE POTENTIALLY AFFECTED PARTS WERE SENT FOR CLEANLINESS TESTING- ALL TESTS WERE WITHIN THE ACCEPTANCE LIMITS. THIS NCR HAS NO INFLUENCE ON THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. THE PFN NAIL IS BROKEN AS COMPLAINED. THE BREAKAGE OCCURRED IN THE REGION BELOW THE NAIL CONUS. THE NAIL PRESENTS NORMAL SIGNS OF USE. DIMENSIONAL INSPECTION: AS RELEVANT FOR THE COMPLAINT CONDITION: ¿NAIL BROKE POSTOPERATIVELY¿, THE FEATURES OUTER AND INNER DIAMETER WERE IDENTIFIED AND MEASURED. THE RELEVANT DIMENSIONS WERE MEASURED NEAR THE BROKEN REGION AND HAVE FULFILLED THE SPECIFICATIONS. BESIDES, DURING THE MANUFACTURING PROCESS THESE FEATURES WERE INSPECTED THROUGH THE INSPECTION SHEET AND NO MANUFACTURING ISSUES WERE FOUND. DRAWING/SPECIFICATION REVIEW: NOT REQUIRED AS ROOT CAUSE IS USE RELATED. MATERIAL REVIEW: THE CERTIFICATE OF THE RAW MATERIAL WAS REVIEWED DURING THE PERFORMED DEVICE HISTORY REVIEW AND MEET SPECIFICATION. THE PFN NAIL IS MADE FROM STAINLESS STEEL. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED; THE PFN NAIL IS BROKEN. THIS PRODUCTION LOT (9669817) WAS MANUFACTURED IN DECEMBER 2015 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. A NON-CONFORMANCE WAS GENERATED DURING PRODUCTION DUE TO A SMOKE ALERT IN THE NAIL DEPARTMENT IN BETTLACH. THE POTENTIALLY AFFECTED PARTS WERE SENT FOR CLEANLINESS TESTING- ALL TESTS WERE WITHIN THE ACCEPTANCE LIMITS. THIS NCR HAS NO INFLUENCE ON THE REPORTED ISSUE. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION AND WE ARE NOT AWARE OF ANY OTHER COMPLAINTS FOR THIS ARTICLE- AND LOT COMBINATION. THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED; A MATERIAL OR MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. DURING THE INVESTIGATION, NO INDICATION FOR A PRODUCT DESIGN OR MANUFACTURING RELATED ISSUE WAS IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). NAIL BROKE APPROXIMATELY ONE YEAR AFTER INITIAL IMPLANTATION, EXACT DATE OF NAIL BREAKAGE IS UNKNOWN. THE (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SUBTROCHANTERIC PROXIMAL FEMORAL NAIL (PFN) BROKE ONE YEAR AFTER IMPLANTATION WITH PSEUDARTHROSIS. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017. REVISION SURGERY WITH REMOVAL OF BROKEN IMPLANT AND RE-IMPLANTATION OF A NEW PFN WAS PERFORMED ON (B)(6) 2018. THERE WAS NO INTRAOPERATIVE PROBLEM DURING THE REVISION. PATIENT OUTCOME IS GOOD. CONCOMITANT DEVICES REPORTED: BOLT Ø4.9 SELF-TAP L34 SST (PART # 259.340, LOT # L073352, QUANTITY 1), HIPPIN Ø6.5 SELF-TAP L75 SST (PART # 234.075, LOT # L134151, QUANTITY 1), FEM-NECKSCR Ø11 SELF-TAP L100 SST (PART # 273.100, LOT # 5941291, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334139 PFN Ø10 CANN R 130° L340 SST ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 9669817 07611819089549

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention