BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS

    MDR report key: 8024261 · Received October 31, 2018

    Report

    Report Number
    8030965-2018-57771
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    January 1, 2018
    Report Date
    October 15, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819760226
    PMA / PMN Number
    K172157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: DHR REVIEW WAS COMPLETED. PART: 04.005.526. LOT: L122774. MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: 07.SEP.2016 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 40 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 TO 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. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. INVESTIGATION SELECTION: INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW(S): 5. BROKEN. VISUAL INSPECTION: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE PART IS BROKEN AS REPORTED, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. IN ADDITION, WE HAVE RECEIVED THE PART WITH THE SCREW HEAD, THE PART WITH THE TIP IS MISSING. FURTHERMORE, THE SCREW RECESS SHOWING SOME SLIGHT SIGNS OF USE (FROM IMPLANTATION AND EXPLANTATION). DOCUMENT/SPECIFICATION REVIEW: DRAWINGS AND REVISIONS ARE IN ACCORDANCE TO DHR OF PRODUCTION LOT L122774. ALL RELEVANT FEATURES ARE DEFINED ON THE USED DRAWING REVISIONS OF DHR OF PRODUCTION LOT L122774. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, 40 PARTS WERE DELIVERED TO THE WAREHOUSE, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE ARTICLE WAS MANUFACTURED IN SEPTEMBER 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. DIMENSIONAL INSPECTION: THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DAMAGE. FURTHERMORE, THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DIMENSIONAL INSPECTION IS NEEDED. SUMMARY: 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, BUT WE HAVE TO ASSUME THAT EXCESSIVE FORCE, LED TO THIS DAMAGE. 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

    DATE OF EVENT: EXACT DATE IS UNKNOWN. (B)(6). (B)(4). THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE (3) TROCHANTERIC FIXATION NAIL (TFN) IMPLANTS BROKE. THESE INVOLVES A TFN NAIL AND TWO LOCKING SCREWS. PATIENT AND SURGICAL OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR NAILS. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864489 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L122774 07611819760226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention