NA 314.132Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034769004), received between Mar 13, 2017 and Oct 11, 2019 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Bent” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF CONSIGNMENTS SETS ON (B)(6) 2019, THE TIP OF A HEXAGONAL SCREWDRIVER WITH T-HANDLE WAS SWIRLED, THE THREADS ON THE TIP OF A THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS WERE DAMAGED, AND A SOCKET WRENCH WOULD NOT HOLD OR SELF RETAIN THE NUT AND THE NUT FALLS OUT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9182895 ↗
• MalfunctionApr 13, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING A REVISION SURGERY THAT THE REMOVAL OF S1 SCREWS THAT TWO IMPLANT HOLDERS BROKE. ADDITIONALLY, WHILE REPLACING THE RIGHT S1 SCREW, TWO UNIVERSAL SPINE SYSTEM-VARIABLE ANGLE SCREWS (USS-VAS) BROKE - (THE LOCKING RING ON THE SCREW BECAME DISLODGED AND WOULD NOT WORK). A THIRD IMPLANT HOLDER BROKE DURING FINAL TIGHTENING, AND A TIP OF THE HOLDER BROKE OFF INTO THE LEFT S1 SCREW AND WAS NOT RETRIEVABLE. IT REMAINED IN THE PATIENT. WHILE INSPECTING THE USS-VAS SCREWDRIVERS, IT WAS DISCOVERED THAT THE TIPS OF THE DRIVERS WERE TWISTED. REPLACEMENTS WERE REQUESTED. THE REVISION SURGERY WAS CAPTURED AS A POSTOPERATIVE EVENT ON A RELATED PRODUCT COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429933 ↗
• MalfunctionApr 13, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING A REVISION SURGERY THAT THE REMOVAL OF S1 SCREWS THAT TWO IMPLANT HOLDERS BROKE. ADDITIONALLY, WHILE REPLACING THE RIGHT S1 SCREW, TWO UNIVERSAL SPINE SYSTEM-VARIABLE ANGLE SCREWS (USS-VAS) BROKE - (THE LOCKING RING ON THE SCREW BECAME DISLODGED AND WOULD NOT WORK). A THIRD IMPLANT HOLDER BROKE DURING FINAL TIGHTENING, AND A TIP OF THE HOLDER BROKE OFF INTO THE LEFT S1 SCREW AND WAS NOT RETRIEVABLE. IT REMAINED IN THE PATIENT. WHILE INSPECTING THE USS-VAS SCREWDRIVERS, IT WAS DISCOVERED THAT THE TIPS OF THE DRIVERS WERE TWISTED. REPLACEMENTS WERE REQUESTED. THE REVISION SURGERY WAS CAPTURED AS A POSTOPERATIVE EVENT ON A RELATED PRODUCT COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429845 ↗
• MalfunctionMar 2, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF CONSIGNMENT SETS IT WAS IDENTIFIED THAT THE DRIVER TIP OF THE 3.0 MM HEXAGONAL SCREWDRIVER WITH T-HANDLE IS BENT. NO PATIENT OR PROCEDURE INVOLVEMENT. DURING MANUFACTURER INVESTIGATION OF THE RETURNED DEVICE, IT WAS IDENTIFIED THAT DRIVE FEATURE OF THE DEVICE IS DAMAGED/WORN/STRIPPED. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON MARCH 1, 2018. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7310549 ↗
• MalfunctionDec 12, 2017Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF CONSIGNMENT INSTRUMENT SET AT THE HOSPITAL, TWO (2) USS VARIABLE AXIS SCREW (VAS) SCREWDRIVER TIPS WERE NOTED TO BE WORN, TWISTED AND NEEDED REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 2 OF 2 FOR PC-(B)(6).

  Patient problems: No Code Available

  MAUDE report 7109934 ↗
• MalfunctionDec 12, 2017Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF CONSIGNMENT INSTRUMENT SET AT THE HOSPITAL, TWO (2) USS VARIABLE AXIS SCREW (VAS) SCREWDRIVER TIPS WERE NOTED TO BE WORN, TWISTED AND NEEDED REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7109919 ↗
• MalfunctionDec 6, 2017Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF IN THE LEFT L5 UNIVERSAL SPINE SYSTEM (USS) VARIABLE AXIS SCREW III (VAS III) DURING PLACEMENT OF THE SCREW ON (B)(6) 2017. THE TIP WAS LODGED IN THE SCREW. THERE WAS A LOT OF TORQUE ON THE DRIVER WHEN THE TIP BROKE. THE SCREW WAS NOT SEATED FULLY. THE SURGEON ELECTED TO REMOVE THE SCREW. THE TIP OF THE SCREWDRIVER WAS REMOVED WITH THE SCREW. THERE WAS FIVE (5) MINUTE SURGICAL DELAY TO REMOVE THE SCREW AND PLACE A NEW ONE. HE PLACED A SHORT ROD ON THIS SCREW AND TIGHTENED THE NUT AND COLLAR AND ROTATED THE SCREW OUT USING THE ROD (HELICOPTER OUT). THE SURGEON THEN PLACED A NEW USS VAS III SCREW IN THE LEFT L5. THE SURGEON THEN SUCCESSFULLY COMPLETED THE STAGE 1 PROCEDURE. THE PATIENT HAD A PREVIOUS POSTERIOR LUMBAR FUSION WITH STRYKER XIA HARDWARE. THE SURGEON PLANNED TO DO A 2-STAGE PROCEDURE. THE 1ST STAGE WAS PLANNED TO REMOVE THE COMPETITIVE HARDWARE AND PLACE SCREWS FROM T10-S1, AND THE 2ND STAGE AT A LATER DATE TO PERFORM A PEDICLE SUBTRACTION OSTEOTOMY AND PLACE THE RODS AND ILIAC SCREWS. CONCOMITANT DEVICE REPORTED: 7.0 MM TI USS VARIABLE AXIS SCREW 50 MM THREAD LENGTH (PART # 499.355, LOT # H335569, QUANTITY 1). THIS REPOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088795 ↗
• MalfunctionSep 20, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE HEX TIP OF THE DRIVER IS STRIPPED. THIS WAS DISCOVERED DURING A ROUTINE INSPECTION OF INSTRUMENTS SETS AT A FACILITY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6880885 ↗
• MalfunctionApr 13, 2017Bent; Bent

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF INSTRUMENT SETS,IT WAS NOTED THAT THE TIPS ARE BENT /SWIRLED ON TWO OF THE 3.0MM HEXAGONAL SCREWDRIVERS DUE TO HIGH TORQUE. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) 3.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6489729 ↗
• MalfunctionApr 13, 2017Bent; Bent

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF INSTRUMENT SETS, IT WAS NOTED THAT THE TIPS ARE BENT /SWIRLED ON TWO OF THE 3.0MM HEXAGONAL SCREWDRIVERS DUE TO HIGH TORQUE. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) 3.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6489686 ↗
• MalfunctionMar 13, 2017Bent; Bent

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF INVENTORY, A 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE INSTRUMENT WAS DISCOVERED TO BE BENT. THERE WAS NO REPORTED PATIENT OR PROCEDURAL INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6398482 ↗