VIPER 279704400Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034301280), received between May 11, 2018 and Mar 2, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION(T10-SAI) PERFORMED ON (B)(6) 2026. WHILE INSERTING THE SAI SCREW, THE PATIENT'S BONE WAS TOO HARD, CAUSING THE TIP OF THE SCREWDRIVER TO BREAK OFF APPROXIMATELY 3 MM. THIS WAS DISCOVERED AFTER THE SCREW WAS INSERTED AND REMOVED, AND IT IS UNCLEAR WHEN IT BROKE. THE BROKEN TIP REMAINED INSIDE THE SCREW, BUT IT WAS ABLE TO BE EXTRACTED USING A K-WIRE. A 9 MM X 90 MM SCREW WAS INSERTED, AND THE TAP WAS ADJUSTED FROM 2 MM UNDER TO A SAME TAP, BUT THE SCREW WAS TOO STRONG. THE SURGEON BELIEVED THAT THE PATIENT'S BONE WAS TOO HARD, CAUSING THE BREAK, AND THERE WERE NO PARTICULAR COMPLAINTS ABOUT THE PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490472 ↗
• MalfunctionSep 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, INSTRUMENTS WERE WORN DOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) QUICK CONNECT T27 POLY DRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775708 ↗
• MalfunctionMay 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT TWO DRIVERS BROKE DURING A CASE ON (B)(6) 2023. THE SIZE 9 DOUBLE LEAD TAP WAS USED PRIOR TO THE SCREW BEING INSERTED, USING A 10 X 110MM SCREW. THE FIRST DRIVER BEGAN TO HAVE ISSUES UPON ADVANCING THE SCREW. THE TULIP HEAD WAS STILL PROMINENT, YET HAD STARTED TO SPIN, AND THE SCREW WOULD NOT ADVANCE FURTHER. THE SURGEON RELEASED THE DRIVER SHAFT THREAD FROM THE TULIP HEAD IN ORDER TO INSPECT THE DRIVER. AT THIS POINT, IT WAS NOTED THAT THE TIP OF THE DRIVER, THE STAR, WAS NO LONGER PRESENT ON THE DRIVER ITSELF, AND WAS IMBEDDED INTO THE SCREW HEAD. THE SCREW WAS STILL PARTIALLY IN THE PATIENT, AND COULD NOT BE REMOVED WITH PILERS, NOR USING A ROD/SET SCREW APPROACH TO HELICOPTER IT OUT OF THE PATIENT. THE SURGEON HAD SCRUBBED IN AT THIS POINT, AND USED A 2MM K-WIRE AND DRILLED IT INTO THE RECESS, REVERSED IT, AND THE PORTION OF THE STAR DRIVE TIP WAS REMOVED. THE SURGEON THEN TRIED TO USE THE SECOND DRIVER ON THE SET IN ORDER TO REMOVE THE SCREW. UNFORTUNATELY, THE SECOND DRIVER WAS ALREADY IN A STATE OF NEEDING REPLACEMENT, AND UNSUCCESSFULLY ENDED WITH THE SAME FATE AS THAT OF THE FIRST DRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859561 ↗
• MalfunctionApr 24, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED ON APRIL, 4, 2023, THAT THE SIZE 9 DOUBLE LEAD TAP WAS USED PRIOR BEFORE THE SCREW WAS INSERTED, USING A 10 X 110MM SCREW. THE FIRST DRIVER BEGAN TO HAVE ISSUES UPON ADVANCING THE SCREW. THE TULIP HEAD WAS STILL PROMINENT, YET HAD STARTED TO SPIN, THE SCREW WOULD NOT ADVANCE FURTHER. THE SURGEON RELEASED THE DRIVER SHAFT THREAD FROM THE TULIP HEAD, IN ORDER TO INSPECT THE DRIVER. AT THIS POINT WE SAW THAT THE TIP OF THE DRIVER, THE STAR, WAS NO LONGER PRESENT ON THE DRIVER ITSELF, AND WAS IMBEDDED INTO THE SCREW HEAD. THE SCREW WAS STILL PARTIALLY IN THE PATIENT, AND COULD NOT BE REMOVED WITH PILERS, NOR USING A ROD/SET SCREW APPROACH TO HELICOPTER IT OUT OF THE PATIENT. SURGEON HAD SCRUBBED IN AT THIS POINT, WE USED A 2MM K-WIRE AND DRILLED IT INTO THE RECESS, REVERSED IT AND THE PORTION OF THE STAR DRIVE TIP WAS REMOVED. WE THEN TRIED TO USE THE SECOND DRIVER ON THE SET IN ORDER TO REMOVE THE SCREW. UNFORTUNATELY, THE SECOND DRIVER WAS ALREADY IN A STATE OF NEEDING REPLACEMENT, AND UNSUCCESSFULLY ENDED WITH THE SAME FATE THAT OF THE FIRST DRIVER BEING USED. ANOTHER 2MM K-WIRE WAS USED, TO DRILL OUT AND REMOVE THE BROKEN TIP FROM THE TULIP HEAD. WE LOCATED AND OPEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16798055 ↗
• MalfunctionOct 4, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN SURGERY FOR THE ILIUM, THE SURGEON ATTEMPTED TO REMOVE A SCREW BECAUSE THE SCREW HEAD CAME TOO DORSAL. THE POLY DRIVER WAS APPLIED TO THE SCREW, BUT THE SCREW WAS EXCESSIVELY TIGHTENED AND COULD NOT BE REMOVED. WHEN TWO SURGEONS TRIED TO REMOVE THE SCREW, THE TIP OF THE POLY DRIVER BROKE. THE BROKEN TIP WAS STUCK IN THE SCREW HEAD, AND THE SCREW HEAD WAS CUT OFF WITH A CUTTER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME IS REPORTED AS STABLE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM LAG SCREW QUICK CONNECT DRIVER 5.5. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15536505 ↗
• MalfunctionMar 4, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON FEBRUARY 4, 2022 A PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE A LOOSE SCREW (DEPLOYED AT S2) WITH A VIPER TI SAI POLY 10X90MM SCREW. THE LOOSE SCREW WAS REMOVED, AND THE SURGEON MOVED ON TO INSERTING THE VIPER TI SAI POLY 10X90MM SCREW. AFTER TAPPING THE TIP OF THE SCREWDRIVER BROKE. AS THE REPLACING SCREW HAD BEEN INSERTED TO A CERTAIN EXTENT, A ROD WAS DEPLOYED OVER THE REPLACING SCREW. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS X-RAYED, AND IT WAS CONFIRMED THAT NO FRAGMENT HAD BEEN LEFT IN THE LESION. THERE WAS A LESS THAN A THIRTY (30) MINUTES SURGICAL DELAY. THE SURGEON COMMENTED THAT THE PATIENT¿S BONE HAD BECOME HARDENED. NO FURTHER INFORMATION IS AVAILABLE. RELATED COMPLAINT (B)(4) CAPTURES THE POSTOPERATIVE LOOSENING OF THE SCREW AFTER THE PRIMARY PROCEDURE. THIS REPORT IS FOR ONE (1) QUICK CONNECT T27 POLY DRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673758 ↗
• MalfunctionJun 11, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SCREWDRIVER IS DAMAGED AT THE TIP. IT WAS NOTICED BEFORE SCREWING IN THE SCREW. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) QUICK CONNECT T27 POLY DRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986244 ↗
• MalfunctionJul 25, 2019Break; Break

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE FOR THE ILIUM ON (B)(6) 2019. WHEN THE REPORTED QC DRIVER (279704400) WAS USED TO INSERT A SCREW INTO THE HARD ILIAC BONE, THE DRIVER¿S TIP BROKE. THE BROKEN TIP WAS REMOVED FROM THE SCREW. NEXT, THE 2ND QC DRIVER (279704400) WAS REPLACED TO REMOVE THE SCREW, BUT THE SAME BREAKAGE OCCURRED. THIS BROKEN TIP WAS ALSO REMOVED. NO FRAGMENT REMAINED IN THE PATIENT¿S BODY, AND IT WAS CONFIRMED BY POSTOPERATIVE X-RAYS. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8825842 ↗
• MalfunctionJul 25, 2019Break

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE FOR THE ILIUM ON (B)(6) 2019. WHEN THE REPORTED QC DRIVER (279704400) WAS USED TO INSERT A SCREW INTO THE HARD ILIAC BONE, THE DRIVER¿S TIP BROKE. THE BROKEN TIP WAS REMOVED FROM THE SCREW. NEXT, THE 2ND QC DRIVER (279704400) WAS REPLACED TO REMOVE THE SCREW, BUT THE SAME BREAKAGE OCCURRED. THIS BROKEN TIP WAS ALSO REMOVED. NO FRAGMENT REMAINED IN THE PATIENT¿S BODY, AND IT WAS CONFIRMED BY POSTOPERATIVE X-RAYS. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8825826 ↗
• MalfunctionMay 11, 2018Break; Break

  ON (B)(6) 2018, THE SURGERY FOR PELVIC FRACTURE WAS PERFORMED USING THE EXPEDIUM SYSTEM. DURING THE SURGERY, AFTER TAPPING WAS COMPLETED, THE TIP OF THE REPORTED DEVICE ((B)(4)) GOT BROKEN DURING USE. THE SURGEON REPLACED THE DEVICE IN QUESTION WITH ANOTHER ONE AND SUCCESSFULLY COMPLETED THE SURGERY. NO BROKEN PIECES WERE FOUND LEFT IN THE PATIENT¿S BODY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508332 ↗