BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID INSERTION HANDLE

    MDR report key: 10015357 · Received April 30, 2020

    Report

    Report Number
    8030965-2020-03229
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 15, 2020
    Report Date
    April 15, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819642379
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H4, H6: PART: 03.037.011, LOT: 9770384, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: FEBRUARY 22, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE RECEIVED INSERT-HANDLE HAS SHOWN NO SIGNIFICANT TRACES OF USE IT IS ONLY PRESENT WEAR MARKS AT THE CONNECTION PARTS (LOCATION NAIL- AND HAMMER GUIDE) ARE VISIBLE. FUNCTIONAL TEST: A FUNCTIONAL TEST WITH THE RETURNED INSERT - HANDLE, TFNA NAIL AND THE CONCOMITANT CONNECTING SCREWS WERE PERFORMED. THE COMPLAINED MALFUNCTION OF "THE LOCKING MECHANISM DIDN¿T WORK" COULD NOT BE REPLICATED. THE RETURNED PARTS PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE ASSEMBLING / DISASSEMBLING AS WELL AS TO SCREW / RELEASE THE COMPLAINED PARTS TOGETHER IS FULL FUNCTIONAL AS INTENDED. NO INTERFERING COULD BE DETECTED. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. DIMENSIONAL INSPECTION: AS THIS INVESTIGATION IS FOCUSED IN THE FUNCTIONAL ISSUE AND THIS WAS COVERED THROUGH THE FUNCTIONAL TEST PERFORMED. THEREFORE, NO MEASUREMENTS OF THE FEATURES ARE REQUIRED. SUMMARY: THE COMPLAINT IS RATED AS UNCONFIRMED FOR THIS RETURNED INSERT - HANDLE BECAUSE THAT THERE IS FULL FUNCTIONAL AS INTENDED. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED HANDLING FAULT AT THE DEVICES. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR PROXIMAL FEMORAL TROCHANTERIC FRACTURES BY USING THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. DURING THE SURGERY, WHILE INSERTING THE NAIL, THE LOCKING MECHANISM OF THE NAIL WOULD NOT ADVANCE. ANOTHER NAIL WAS USED AND THE INSERTION WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY. CONCOMITANT DEVICE: CANNULATED CONNECTING SCREW (PART# 03.037.010, LOT# 9667929, QUANTITY 1), T-HANDLE BALL HEXAGONAL SCREWDRIVER (PART# 03.010.517, LOT# 9642328, QUANTITY 1), CANNULATED CONNECTING SCREW (PART# 03.037.010, LOT# 9667930, QUANTITY 1). THIS REPORT IS FOR ONE (1) HYBRID INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476746 HYBRID INSERTION HANDLE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 9770384 07611819642379

    Patients

    Seq Age Sex Outcome Treatment
    1 CONNECSCR F/INSERTION HANDLE| CONNECSCR F/INSERTION HANDLE| SCRDRIVER-HEX Ø8 W/T-HANDLE W/SPHERIC-HE