BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFN Ø10 CANN R 130° L340 SST

    MDR report key: 8529402 · Received April 18, 2019

    Report

    Report Number
    8030965-2019-62933
    Event Type
    Injury
    Date Received
    April 18, 2019
    Report Date
    March 26, 2019
    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
    OTHER HEALTH CARE 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. ADDITIONAL PATIENT IDENTIFIER: (B)(6). X-RAY AND PICTURE REVIEW WAS CONDUCTED AND NARRATIVE (NAIL BREAKAGE) COULD BE VERIFIED FROM PROVIDED X-RAYS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 273.345, LOT: 2173808, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 08 FEB 2006. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE 6653 (9011520) WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO ISO-5832-1 SPECIFICATION. A PRODUCT INVESTIGATION WAS CONDUCTED. A BROKEN PFN NAIL WAS RETURNED FOR INVESTIGATION. IMPLANT WAS FORWARDED TO THE MANUFACTURING SITE AND WAS CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS. SUMMARY OF THE MANUFACTURING EVALUATION: THE PFN NAIL IS BROKEN AT THE BIGGER PROXIMAL HOLE. BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT AGREES WITH THE COMPLAINT DESCRIPTION ¿A BROKEN PFN NAIL¿ AS CLAIMED BY THE CUSTOMER. THUS, THE COMPLAINT IS CONFIRMED. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW NO ISSUES WERE IDENTIFIED. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THIS PFN NAIL WAS MANUFACTURED IN FEBRUARY 2006 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE DIMENSIONAL RE-INSPECTION, THE RAW MATERIAL CERTIFICATE REVIEW AND THE DOCUMENT/SPECIFICATION REVIEW DIDN¿T IDENTIFY ANY MANUFACTURING DEFECT OR DEFICIENCY, THUS THE COMPLAINT INVESTIGATION IS CONSIDERED AS NOT MANUFACTURING RELATED. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED. 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

    FURTHER IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 DUE TO A BROKEN PROXIMAL FEMORAL NAIL (PFN) NAIL. INITIALLY, THE PATIENT WAS IMPLANTED WITH PFN SYSTEM ON (B)(6) 2009. HOWEVER, IN (B)(6) 2019, THE PATIENT FELL WHICH RESULTED A PROXIMAL FEMORAL FRACTURE. AN X-RAY WAS TAKEN ON (B)(6) 2019, AND CONFIRMED A BROKEN PFN NAIL. THUS, A HARDWARE REMOVAL WAS PERFORMED AND THE PATIENT WAS REVISED TO A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) WITH THE SAME DIMENSION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: END CAP FOR PFN (PART# 273.150, LOT# 2421749, QUANTITY# 1), HIP PIN (PART# 234.075, LOT# 1959663, QUANTITY# 1), FEMORAL NECK SCREW (PART# 273.100, LOT# UNKNOWN, QUANTITY# 1), DISTAL LOCKING BOLT (PART# 259.380, LOT# 1941096, QUANTITY# 1), DISTAL LOCKING BOLT (PART# 259.340, LOT# 1981246, QUANTITY# 1). THIS REPORT IS FOR ONE (1) PFN NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319594 PFN Ø10 CANN R 130° L340 SST ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 2173808 07611819089549

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention