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VIPER 286725020Recalls & reported problems

Depuy Spine, LLC · VIPER 2 SYSTEM DRIVER, CANNULATED T20 · Class 1

All models of VIPER (60)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This DePuy Spine Viper 2 cannulated screwdriver is used to place screws in the spine during surgery. Most of the 48 reports describe the shaft breaking, bending or twisting during use, and in several cases a broken piece stayed stuck in the patient or the operation was delayed while it was retrieved. There are 4 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
48
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10705034214290), received between Oct 17, 2017 and Feb 20, 2026 — classified as 4 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break34
  • Material Twisted/Bent12
  • Entrapment of Device2
  • Material Deformation2
  • Material Integrity Problem2
  • Scratched Material2
  • Detachment Of Device Component1
  • Device-Device Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions28
  • No Consequences Or Impact To Patient14
  • Foreign Body In Patient4
  • Not Applicable4
  • No Code Available2
  • No Patient Involvement2
  • Foreign Body Reaction1
  • Injury1

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 20, 2026Break; Material Twisted/Bent; Scratched Material

    IT WAS REPORTED WHILE INSERTING THE SCREW, A STRIPPING SOUND WAS HEARD, AND UPON CHECKING, IT WAS FOUND THAT THE GROOVE IN THE SCREWDRIVER HAD BEEN GOUGED OUT. WHEN THE SURGEON USED A SPARE SCREWDRIVER TO INSERT IT, THE OTHER SCREWDRIVER BROKE. THE BROKEN PART WAS REMOVED USING TWEEZERS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24400412 ↗
  • MalfunctionFeb 20, 2026Break; Material Twisted/Bent; Scratched Material

    IT WAS REPORTED WHILE INSERTING THE SCREW, A STRIPPING SOUND WAS HEARD, AND UPON CHECKING, IT WAS FOUND THAT THE GROOVE IN THE SCREWDRIVER HAD BEEN GOUGED OUT. WHEN THE SURGEON USED A SPARE SCREWDRIVER TO INSERT IT, THE OTHER SCREWDRIVER BROKE. THE BROKEN PART WAS REMOVED USING TWEEZERS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24400388 ↗
  • MalfunctionAug 21, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT THE SALES REP WAS INFORMED BY THE J&J¿S DISTRIBUTOR ON (B)(6) 2025, THAT THE DRIVER SHAFTS IN QUESTION HAD BEEN STRIPPED SEVERAL PREVIOUS SURGERIES, MAKING SCREW INSERTION DIFFICULT. WHEN THE SALES REP CHECKED THE PRODUCTS IN QUESTION, HE FOUND THAT THE THREADS AT THE TIP WERE STRIPPED. NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22863830 ↗
  • MalfunctionAug 21, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT THE SALES REP WAS INFORMED BY THE J&J¿S DISTRIBUTOR ON (B)(6) 2025, THAT THE DRIVER SHAFTS IN QUESTION HAD BEEN STRIPPED SEVERAL PREVIOUS SURGERIES, MAKING SCREW INSERTION DIFFICULT. WHEN THE SALES REP CHECKED THE PRODUCTS IN QUESTION, HE FOUND THAT THE THREADS AT THE TIP WERE STRIPPED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22863106 ↗
  • MalfunctionJul 29, 2025Break; Entrapment of Device; Break; Entrapment of Device

    IT WAS REPORTED THAT DURING A REMOVAL SURGERY PERFORMED ON (B)(6) 2025, WHEN THE SURGEON WAS REMOVING THE XTAB SCREW, THE TIP OF THE DRIVER SHAFT WAS DAMAGED AND REMAINED EMBEDDED, MAKING IT DIFFICULT TO REMOVE. THE SURGEON CLOSED THE WOUND, LEAVING THE SCREW IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

    MAUDE report 22650171 ↗
  • MalfunctionMay 8, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT A VIPER SCREW DRIVER BROKE AND OTHER TWO STRIPPED INTRAOPERATIVELY. THERE WAS A 5 MINUTES SURGICAL DELAY. PATIENT STATUS IS REPORTED AS GOOD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21987144 ↗
  • MalfunctionJul 23, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

    IT WAS REPORTED THAT PATIENT UNDERWENT PERCUTANEOUS PEDICLE SCREW (PPS) (LUMBAR VERTEBRAE L5) FOR PYOGENIC SPONDYLITIS ON (B)(6). 2024. IN THE SURGERY, THE SCREWDRIVER SHAFT IN QUESTION WAS ATTEMPTED TO BE USED, BUT THE TIP OF THE PRODUCT WAS BENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES SURGICAL DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A VIPER2 T20 HEXLOBE DRIVER SHAF. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19806215 ↗
  • MalfunctionDec 18, 2023Break; Break

    DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING THE CLEANING PROCESS, IT WAS DISCOVERED THAT THE TIP OF THE SCREWDRIVER IN QUESTION WAS BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM DRIVER, CANNULATED T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18347410 ↗
  • MalfunctionOct 4, 2023Material Twisted/Bent; Material Twisted/Bent

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWDRIVER T20 DID NOT TAKE THE SCREWS OF THE SYSTEM VIPER2 PROPERLY. WHEN MAKING THE REDUCTION AND POSITIONING THE REDUCTION SLEEVES, THEY DO NOT SLIDE EASILY. THERE WAS NO INVOLVEMENT IN THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 T20 HEXLOBE DRIVER SHAF THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17868774 ↗
  • MalfunctionMay 11, 2023Break; Break

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE SURGERY WITH THE DRIVER SHAFT IN QUESTION. IN THE SURGERY, THE DRIVER SHAFT HAS FAILED. DETAILS OF THE PROBLEM ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) VIPER2 T20 HEXLOBE DRIVER SHAF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16912378 ↗
  • MalfunctionOct 4, 2022Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER STRIPPED IN THE MIDDLE OF A CASE WHEN TRYING TO BACK OUT A SCREW. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM DRIVER, CANNULATED T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15536274 ↗
  • MalfunctionAug 19, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT WAS X-RAYED AFTER SCREW INSERTION. IT WAS CONFIRMED THAT THE SCREW IN QUESTION HAD COME OFF THE LESION. WHEN THEY TRIED TO RETRACT THE SCREW WITH THE DRIVER SHAFT, THE TIP OF THE DRIVER SHAFT BROKE OFF. A FRAGMENT WHICH HAD STUCK TO THE SCREW WAS REMOVED FROM THE LESION. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THE PATIENT¿S BONE WAS QUITE HARD, SO THE SURGEON HAD DIFFICULTY IN THE SCREW INSERTION. PATIENT STATUS/ OUTCOME: THE PATIENT WAS X-RAYED, AND IT WAS CONFIRMED THAT NO FRAGMENT HAD BEEN LEFT IN THE LESION. THIS REPORT IS FOR ONE (1) VIPER2 T20 HEXLOBE DRIVER SHAF. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15262350 ↗
  • MalfunctionJul 6, 2022Break; Break

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PCF REVISION PROCEDURE THE TIP OF THE DRIVER SHAFT BROKE OFF DURING SCREW INSERTION. A REPLACEMENT DRIVER SHAFT WAS USED, AND AGAIN THE TIP OF THE SHAFT BROKE OFF. THE PROCEDURE WAS DELAYED BY LESS THAN 30 MINUTES. THIS REPORT IS FOR A VIPER 2 SYSTEM DRIVER, CANNULATED T20. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14932017 ↗
  • MalfunctionJul 6, 2022Break; Break

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PCF REVISION PROCEDURE THE TIP OF THE DRIVER SHAFT BROKE OFF DURING SCREW INSERTION. A REPLACEMENT DRIVER SHAFT WAS USED, AND AGAIN THE TIP OF THE SHAFT BROKE OFF. THE PROCEDURE WAS DELAYED BY LESS THAN 30 MINUTES. THIS REPORT IS FOR A VIPER 2 SYSTEM DRIVER, CANNULATED T20. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14931975 ↗
  • MalfunctionDec 6, 2021Material Twisted/Bent; Material Twisted/Bent

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT THE POSTERIOR SPINAL FUSION (L3-L5) ON AN UNKNOWN DATE. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PROLONGATION OF POSTERIOR SPINAL FUSION (L1-S) FOR THE LUMBAR SPINAL STENOSIS WAS PERFORMED. DURING THE SCREW (L3/RIGHT) REMOVAL, THE HEXLOBE DRIVER SHAFT WAS STRIPPED. THEREFORE, REMOVAL WAS ATTEMPTED USING VIPER UNIVERSAL PLY DRIVER. HOWEVER, THE DRIVER'S TIP BROKE. THE SCREW WAS REMOVED AS PER SURGICAL TECHNIQUES. THE BROKEN FRAGMENTS WERE REMOVED FROM THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 T20 HEXLOBE DRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12938903 ↗
  • MalfunctionOct 26, 2021Break; Break

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SPINAL FUSION (L1) TO TREAT DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS (DISH), THE TIP OF THE DRIVER SHAFT BROKE OFF DURING THE EXTRA SCREW TIGHTENING AGAINST THE HARDENED BONE. THE FRAGMENT WAS REMOVED FROM THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH LESS THAN A 30-MINUTE SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM DRIVER, CANNULATED T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12697950 ↗
  • MalfunctionOct 20, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN ANTERIOR/POSTERIOR LUMBAR FUSION PROCEDURE, , ONE (1) VIPER UNIVERSAL POLY DRIVER WAS BROKEN, AND TWO (2) T20 DRIVER SHAFTS WERE STRIPPED. THE SURGEON WAS PLACING UNKNOWN SCREWS IN THE PATIENT WHEN TWO (2) POLY SCREWDRIVER SHAFTS TIPS BROKE OFF. HE THEN ATTEMPTED TO USE THE VIPER2 T20 HEXLOBE DRIVER AND T20 SCREWDRIVER SHAFT WHICH BOTH STRIPPED. HE ADVANCED USING THE VIPER UNIVERSAL POLY DRIVER AND THE TIP OF THE DRIVER WAS FOUND TO BE BROKEN ON THE BACK TABLE AFTER IT WAS TAKEN OUT. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VIPER2 T20 HEXLOBE DRIVER SHAFT. THIS IS REPORT 1 OF 5 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12665928 ↗
  • MalfunctionOct 19, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING SCREW REMOVAL, THE TIP OF THE VIPER T20 HEXLOBE DRIVER SHAFT BROKE. THE SURGEON HAD DIFFICULTY REMOVING A ROD WITH THE UNI PLATE HOLDER WHICH RESULTED IN THE HOLDER'S DEFORMATION. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 T20 HEXLOBE DRIVER SHAF. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12656369 ↗
  • MalfunctionSep 27, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE DRIVER SHAFT AND THE POLY DRIVER WERE RECEIVED BACK TO THE MANUFACTURER BROKEN. THIS REPORT IS FOR A VIPER2 T20 HEXLOBE DRIVER SHAF. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12537052 ↗
  • MalfunctionAug 17, 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 POSTERIOR PERCUTANEOUS FUSION (L5) TREATING SPINAL CANAL STENOSIS SURGERY. DURING THE SURGERY, THE SURGEON TRIED TO INSERT THE XTAB SCREW (UNK) TO THE HARDENED BONE. AS IT BECAME DIFFICULT TO CONTINUE THE INSERTION, HE DECIDED TO REMOVE THE SCREW. WHILE THE DRIVER SHAFT WAS IN USE FOR SCREW REMOVAL, THE TIP OF THE DRIVER SHAFT BROKE. THE FRAGMENT WAS REMOVED FROM THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER2 T20 HEXLOBE DRIVER SHAF. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12333607 ↗
  • MalfunctionJun 14, 2021Break; Break

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 A SPINAL FUSION AT S1 TREATING DEGENERATIVE DISEASE WAS PERFORMED. THE VIPER SCREW (6MM IN DIAMETER) WAS EXTRACTED FIRST, THEN THE XTAB 7MM CORTICAL SCREW WAS INSERTED WITHOUT TAPPING. FINALLY, THE DRIVER SHAFT WAS USED FOR MINOR INSERTION DEPTH ADJUSTMENT. HOWEVER, TORQUE WAS EXCESSIVELY IN ACTION AND THE TIP OF THE DRIVER SHAFT BROKE. THE FRAGMENT WAS UNABLE TO BE REMOVED AND WAS LEFT IN THE XTAB¿S SCREWHEAD. CONCOMITANT DEVICE: UNKNOWN TORQUE DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM DRIVER, CANNULATED T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11995236 ↗
  • InjuryJun 9, 2021Break; Entrapment of Device; Break; Entrapment of Device

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A LUMBAR INTERBODY FUSION AT L5 TREATING LUMBAR SPINAL CANAL STENOSIS ON (B)(6), 2021. THE SCREW PROCEEDED DEEPER THAN EXPECTED, THE SURGEON TRIED TO PUT IT BACK WHEN THE SCREWDRIVERS TIP BROKE. ACCORDING TO THE SURGEONS COMMENT, THE BONE HAD BEEN HARDENED, AND THE SCREW WAS TIGHTLY FIXATED, SO, HE DECIDED NOT TO EXTRACT BOTH THE SCREW AND SCREWDRIVERS FRAGMENT. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 T20 HEXLOBE DRIVER SHAF. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Patient problems: Foreign Body In Patient

    MAUDE report 11970399 ↗
  • MalfunctionJun 9, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A POSTERIOR SPINAL FUSION SURGERY THE VIPER2 T20 HEXLOBE DRIVER SHAFT WAS BEING USED IN A PERCUTANEOUS SCREW CASE. THE DRIVER TIP WAS BROKEN OFF AND RETRIEVED BY THE SURGEON. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM DRIVER, CANNULATED T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11969784 ↗
  • MalfunctionApr 22, 2021Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event

    ADDITIONAL EVENT DESCRIPTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11710609 ↗
  • MalfunctionApr 14, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON USED CUSTOM AWLS TO ACCESS THE PEDICLE, AND THEN INSERTED THE 7.0X50MM CORTICAL FIX SCREW AT L5 ON THE RIGHT SIDE. AS THE SCREW WAS BEING INSERTED THE TULIP HEAD POPPED OFF DISENGAGING FROM THE BODY OF THE SCREW. THE SURGEON ATTEMPTED TO REMOVE THE BODY OF THE SCREW WITH A T20 DRIVER BUT STRIPPED THE T20 CANNULATED DRIVER. THE SURGEON ALSO STRIPPED THE T20 NON CANNULATED DRIVER AND FRACTURED THE TIP OF THE MINI OPEN DRIVER. THE BROKEN TIP OF THE MINI OPEN DRIVER WAS POSSIBLY INSIDE THE HEX OF THE SCREW. THE NEXT ATTEMPT TO REMOVE THE SHAFT OF THE SCREW WAS TO USE A SCREW REMOVAL REVERSE THREAD INSTRUMENT, WHICH FAILED TO REMOVE THE SCREW. THE SURGEON WAS ABLE TO SUCCESSFULLY REMOVE THE FRACTURED INSTRUMENT AND CONFIRMED WITH BOTH X-RAY AND MATCHING IT UP, THAT THE INSTRUMENT WAS REMOVED. THE SCREW REMAINED IN THE PATIENT WITH A RESCUE SCREW 5.0X50MM PLACED DIRECTLY BESIDE IT. TO INSERT THE RESCUE SCREW, THE SURGEON USED A JAM SHIDI, AND GUIDE WIRE WITH 4.35MM TAP. THE RESCUE SCREW HAD NO ISSUE, AND THE SURGEON WAS ABLE TO PASS THE ROD AND FINISH UP. THE TULIP WAS RECOVERED, THE SHAFT OF THE 7.0X50MM SCREW REMAINS IN THE PATIENT, THE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11666069 ↗

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