BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM

    MDR report key: 11931079 · Received June 3, 2021

    Report

    Report Number
    3000931034-2021-00261
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 4, 2021
    Report Date
    November 5, 2021
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HTW
    UDI-DI
    03700386943775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H3 AND H6 DEVICE CODE. THE REPORTED EVENT THAT THE SCREWDRIVER WAS ALLEGED OF ISSUE ¿INSTRUMENT - BREAKAGE DURING IMPLANTATION¿ COULD BE CONFIRMED, SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE DEVICE WAS RECEIVED WITH BROKEN TIP. THE BROKEN TIP OF THE HEXAGONAL SCREWDRIVER RUPTURE CORRESPONDED TO A FRACTURE CAUSED BY A TORSIONAL OVERLOAD, WHERE THE TIP TWISTED-OFF IN THE RIGHT DIRECTION (DURING SCREW TIGHTENING, CONFIRMED BY THE DIRECTION OF MATERIAL DEFORMATION AT THE BREAKAGE LINE). A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY AN OVERSTRESS APPLIED ON THE TIP DURING USE WHEN TIGHTENING THE SCREW INSIDE THE GLENOSPHERE. IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    (B)(6) 2021 -THE SURGEON WAS PERFORMING A REVERSE TOTAL SHOULDER ARTHROPLASTY TODAY ON A NICKEL ALLERGY PATIENT, AND WHILE ATTEMPTING TO TIGHTEN DOWN A TITANIUM 36/25 GLENOSPHERE, A BRAND NEW 3.5 HEX DRIVER TIP BROKE OFF ONTO THE GLENOSPHERE. HE WAS ON HIS FINAL TURN WHEN THE TIP SNAPPED OFF. WE ATTEMPTED TO USE A DENTAL PICK AND A FEW DIFFERENT BURRS TO LOOSEN THE TIP, BUT NO LUCK. THE TIP OF THE HEX DRIVER WAS FLUSH INSIDE OF THE SPHERE. THE SURGEON DID NOT THINK THE GLENOSPHERE OR BASEPLATE HAD BEEN COMPROMISED AND DECIDED TO LEAVE THE TIP IN. THERE WAS NO REPORTED DELAY OR ADVERSE CONSEQUENCE. THE TIP THAT WAS LEFT IN THE GLENOSPHERE WAS VERY SMALL, IT ENDED UP BEING FLUSH.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2021 -THE SURGEON WAS PERFORMING A REVERSE TOTAL SHOULDER ARTHROPLASTY TODAY ON A NICKEL ALLERGY PATIENT, AND WHILE ATTEMPTING TO TIGHTEN DOWN A TITANIUM 36/25 GLENOSPHERE, A BRAND NEW 3.5 HEX DRIVER TIP BROKE OFF ONTO THE GLENOSPHERE. HE WAS ON HIS FINAL TURN WHEN THE TIP SNAPPED OFF. WE ATTEMPTED TO USE A DENTAL PICK AND A FEW DIFFERENT BURRS TO LOOSEN THE TIP, BUT NO LUCK. THE TIP OF THE HEX DRIVER WAS FLUSH INSIDE OF THE SPHERE. THE SURGEON DID NOT THINK THE GLENOSPHERE OR BASEPLATE HAD BEEN COMPROMISED AND DECIDED TO LEAVE THE TIP IN. THERE WAS NO REPORTED DELAY OR ADVERSE CONSEQUENCE. THE TIP THAT WAS LEFT IN THE GLENOSPHERE WAS VERY SMALL, IT ENDED UP BEING FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831889 AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM SURGICAL SCREWDRIVER, REUSABLE HTW TORNIER S.A.S. DIAM 3.5MM LENGTH 25MM 6001AV 03700386943775
    831890 AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM SURGICAL SCREWDRIVER, REUSABLE HTW TORNIER S.A.S. DIAM 3.5MM LENGTH 25MM 6001AV 03700386943775

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other