BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULIFT VBR SZ.M 4MM SET SCREW DRIVER

    MDR report key: 9831100 · Received March 13, 2020

    Report

    Report Number
    2916714-2020-00066
    Event Type
    Malfunction
    Date Received
    March 13, 2020
    Date of Event
    November 29, 2019
    Report Date
    October 8, 2021
    Manufacturer
    AESCULAP INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4- UDI. ASSOCIATED MEDWATCHES: 2916714-2020-00067, 2916714-2020-00066, 2916714-2020-00065. PART MF790R WITH BATCH 2516725A WAS RETURNED WITH THE COMPLAINT OF TWISTED TIP(S). MATERIAL ANALYSIS: TESTING DEMONSTRATED THAT LL OF THE 3 SCREWDRIVES TESTED WERE BELOW HARDNESS SPECIFICATION BY APPROXIMATELY 2 HRC. ALL SCREWDRIVERS ALSO SHOWED SIGNIFICANT PLASTIC DEFORMATION AFTER ONLY ONE CYCLE OF TESTING AT 3.08NM. THIS TESTING SUGGESTED THAT MATERIAL CHOICE FOR THE SCREWDRIVER MAY NOT BE ADEQUATE, AND THAT MORE INVESTIGATION WAS REQUIRED. NOTE: MF790R CONNECTS TO A TORQUE-LIMITING HANDLE, FW129R, WITH SPECIFICATIONS OF 2.8NM +/- 10%. AT THE LOW END, THE TORQUE LIMITATION WOULD BE 2.52NM AND AT THE HIGH END, IT WOULD BE 3.08NM. FINITE ELEMENT ANALYSIS (FEA) WAS PERFORMED. EVEN IF THE HARDNESS WAS IN SPECIFICATION DURING THE TESTING PERFORMED IN ER21-0023, TESTING WOULD HAVE LIKELY STILL FAILED. THE FEA PROVIDES SUPPORT FOR THIS ASSUMPTION BASED ON THE SIGNIFICANT STRESSES AND STRAINS. BASED ON THIS ANALYSIS, IT IS RECOMMENDED THAT A DIFFERENT MATERIAL IS CHOSEN FOR MF790R AS THE CURRENT MATERIAL SELECTION IS NOT APPROPRIATE FOR THE INTENDED USE OF THE DEVICE. DEVICE HISTORY REVIEW: IT WAS REVIEWED AND VERIFIED HARDNESS IS IN SPECIFICATION. VERIFIED THE DIMENSIONAL INSPECTIONS ARE WITHIN SPECIFICATIONS BASED ON THE DRAWING MF790R V04. DID NOT RECEIVE INFORMATION FROM THE SUPPLIER ON THE HEAT TREATMENT PROCESS. DISCUSSION AND CONCLUSION: INSPECTION DETERMINED THAT THE HARDNESS FOR ALL THREE SCREWDRIVERS WERE OUT OF SPECIFICATION. THE AVERAGE HARDNESS WAS 46.1HRC, BUT THE SPECIFICATION IS BETWEEN 48-52HRC. ALL SCREWDRIVERS SHOWED SIGNIFICANT PLASTIC DEFORMATION AFTER ONLY ONE TEST CYCLE. A LOW HARDNESS COULD CONTRIBUTE TO THE FAILURE SEEN IN THE TESTING, HOWEVER, WITH SUCH SIGNIFICANT DEFORMATION OBSERVED, OTHER FACTORS, INCLUDING MATERIAL CHOICE FOR THE INSTRUMENT SHOULD BE INVESTIGATED. ROOT CAUSE: AESCULAP DESIGN PROCESS DOES NOT HAVE A PROCEDURE TO SELECT PART MATERIAL FOR THE INTENDED USE AND AN INCORRECT MATERIAL WAS SPECIFIED FOR THE DESIGN OF MF790R RESULTING TO FAILURE. CORRECTIVE ACTIONS: A CHANGE CONTROL WAS INITIATED FOR MATERIAL SELECTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SPINAL INSTRUMENTS. DURING A CORPECTOMY, THE TIP OF THE SCREWDRIVER WAS TWISTED. REPLACED AND NEW DRIVER TIP TWISTED AFTER 1 USE. THERE WAS NO KNOWN HARM TO THE PATIENT AND NO FURTHER INTERVENTION REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. ASSOCIATED MEDWATCHES: 2916714-2020-00067, 2916714-2020-00065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295402 MODULIFT VBR SZ.M 4MM SET SCREW DRIVER SPINE SURGERY HXX AESCULAP INC MF790R 2516725A

    Patients

    Seq Age Sex Outcome Treatment
    1