VIPER PRIME 286750035Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705034507620), received between Aug 17, 2020 and Mar 6, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT THE HANDLE IS BROKEN INTRAOPERATIVELY. BROKEN IN SEVERAL PIECES DURING USE/PLACEMENT OF PEDICLE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530013 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT THE VIPER PRIME T HANDLE SNAPPED UNDER NORMAL USE DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267711 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT THE VIPER PRIME BLACK HANDLES ALL BROKE DURING SURGERY. 3 IN TOTAL. NO DELAY IN SURGERY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920621 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT THE VIPER PRIME BLACK HANDLES ALL BROKE DURING SURGERY. 3 IN TOTAL. NO DELAY IN SURGERY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920608 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT THE VIPER PRIME BLACK HANDLES ALL BROKE DURING SURGERY. 3 IN TOTAL. NO DELAY IN SURGERY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920601 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT THE VIPER PRIME SCREWDRIVER T HANDLE BROKE WHEN WAS BEING HAMMERED. THERE WAS NO SURGERY DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21094046 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. WHEN USING THE "T" HANDLE, IT BROKE WHEN TIGHTENING THE LOCKING NUTS. NO FRAGMENTS WERE GENERATED. CHANGED TO ANOTHER T HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NINETY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A VIPER PRIME T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735147 ↗
• MalfunctionDec 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS HAMMERING THE VIPER PRIME SCREWDRIVER WITH THE T-HANDLE, AND GIVEN THE PATIENT¿S HARD BONE, THE SURGEON WAS HAMMERING VERY HARD AND FINALLY BROKE THE T-HANDLE. THERE WAS NO CONSEQUENCE TO THE PATIENT. THE SURGEON USED ANOTHER HANDLE TO COMPLETE THE PROCEDURE WITH NO DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER PRIME T-HANDLE. THIS IS REPORT 1OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275450 ↗
• MalfunctionDec 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE ITEM WAS BROKEN DURING SURGERY. THE PATIENT STATUS WAS REPORTED TO BE FINE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ANY MORE INCIDENTS. THERE WAS A DELAY DUE TO THE BREAKAGE, AS ONE OF THE DOCTORS HAD TO WAIT UNTIL THE OTHER HAD FINISHED HIS SIDE. THE DELAY WAS AROUND 15 MINUTES. FRAGMENTS WERE GENERATED AND REMOVED WITH FORCEPS, AS THE FRAGMENTS WERE BIG ENOUGH TO REMOVE THEM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942098 ↗
• MalfunctionDec 5, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE VIPER T HANDLE HAD BROKEN IN TWO. THIS CASE WAS REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915338 ↗
• MalfunctionMay 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRIA AS FOLLOWS: IT WAS REPORTED THAT A TEST PHASE WITH THE PERCUTANEOUS STABILIZATION SYSTEM "VIPER PRIME" IN COMBINATION WITH THE NAVIGATION SYSTEM FROM BRAINLAB IN THE CONTEXT OF A PATIENT-SPECIFIC PATIENT INDICATION WAS OCCURRING AT THE (B)(6) / DEPARTMENT OF NEUROSURGERY. VARIOUS ORTHOKITS OF THE NAVIGABLE VIPER PRIME SYSTEM (INSTRUMENTS AND IMPLANTS) WERE STATIONED ON SITE. INSTRUCTION OF THE INSTRUMENTS WAS CONDUCTED ON SITE. DUE TO THE COMPLEXITY OF THE NAVIGATED VIPER PRIME SETTINGS, IT WAS ALSO VERBALLY AGREED WITH THE USERS THAT ANY OPERATIONS WITH THIS NAVIGABLE VIPER PRIME SET OF INSTRUMENTS MAY ONLY BE CARRIED OUT BY A SURGICAL ASSISTANT OR BY A REPRESENTATIVE. UP TO (B)(6) 2021, ABOUT 2-3 ACCOMPANIED SURGERIES OF THIS TYPE WERE SUCCESSFULLY CARRIED OUT BY DR (B)(6). A SURGERY WAS PLANNED FOR (B)(6) 2021. NO OBJECTION TO CARRYING OUT SUCH SURGERIES EXCLUSIVELY WITH A SURGICAL ACCOMPANIMENT FROM A SYNTHES REPRESENTATIVE WAS JUSTIFIED IN SUCH A WAY THAT THE USERS ARE SUFFICIENTLY FAMILIAR WITH THIS SYSTEM AND THAT ALL IMPLANTS ARE COMPLETE. DR. (B)(6) ON (B)(6) 2022 REPORTED OVER THE PHONE ABOUT A PATIENT SPECIFIC CASE W

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14377877 ↗
• MalfunctionMar 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE VIPER PRIME HANDPIECE BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OTHER AVAILABLE HANDPIECES. NO FRAGMENTS WERE GENERATED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) VIPER PRIME T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693038 ↗
• MalfunctionJul 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE NURSE WANTED TO REMOVE THE PRIME STYLET DEPTH ADJUSTOR FROM THE SCREWDRIVER TO ADAPT THE STYLET DEPTH. WHILE REMOVING IT, IT GOT STUCK IN THE T-HANDLE. IT WAS NOT POSSIBLE TO REMOVE EITHER OF THE ARTICLES FROM THE SCREWDRIVER. THE DEPTH ADJUSTER WAS PUSHED BACK WITH A HAMMER AND THE T-HANDLE WAS REMOVED. THE HEIGHT WAS THE ABLE TO BE ADJUSTED. THERE WAS A TWO (2) MINUTE SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER PRIME T-HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174385 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING ASSEMBLY OF THE VIPER PRIME INSERTER, THEY WERE UNABLE TO INTRODUCE THE STYLET GAUGE INTO THE TOP OF THE INSTRUMENT DUE TO REPETITIVE IMPACT DAMAGE TO THE TOP OF BOTH T-HANDLES. THE STYLET GAUGE THEN NEEDED TO BE INTRODUCED WITHOUT THE HANDLE IN-SITU, WITH THE HANDLE THEN APPLIED RETROSPECTIVELY. THIS WAS DONE FOR BOTH INSERTERS. NO IMPACT OR DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032159 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING ASSEMBLY OF THE VIPER PRIME INSERTER, THEY WERE UNABLE TO INTRODUCE THE STYLET GAUGE INTO THE TOP OF THE INSTRUMENT DUE TO REPETITIVE IMPACT DAMAGE TO THE TOP OF BOTH T-HANDLES. THE STYLET GAUGE THEN NEEDED TO BE INTRODUCED WITHOUT THE HANDLE IN-SITU, WITH THE HANDLE THEN APPLIED RETROSPECTIVELY. THIS WAS DONE FOR BOTH INSERTERS. NO IMPACT OR DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031998 ↗
• MalfunctionMay 5, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE SURGICAL PROCEDURE, THE IMPACTION OF THE VIPER PRIME SCREWDRIVER WAS BEING USED TO INTRODUCE THE STYLET AND THE PIECE OF THE BLACK T-HANDLE BROKE. THE PIECE WAS CHANGED FOR ANOTHER THAT COMES IN THE SET. THE PROCEDURE WAS COMPLETED SATISFACTORILY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) VIPER PRIME T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776775 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS FURTHER REPORTED THAT THERE WERE NO FRAGMENTS GENERATED DURING THE PROCEDURE. THERE WAS NO DELAY IN THE SURGERY AND PATIENT OUTCOME IS REPORTED AS SATISFACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748425 ↗
• MalfunctionMar 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021 DURING THE PROCEDURE, ONE (1) UNKNOWN SCREWDRIVER, ONE (1) VIPER PRIME HANDLE, AND ONE (1) PRIME STYLET DEPTH ADJUSTOR WERE UNABLE TO BE DISASSEMBLED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER SCREWDRIVER IN THE SET. THIS REPORT IS FOR ONE (1) VIPER PRIME T-HANDLE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11489610 ↗
• MalfunctionAug 17, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A POSTERIOR SPINAL FUSION ON (B)(6) 2020 A VIPER T-HANDLE BROKE AND THE INSERTION INSTRUMENT BECAME BENT. THE SURGEON USED A VIPER PRIME SCREW DRIVER TO INSERT THE SCREW. AS THE SURGEON BACKED THE DRIVER OUT ONCE THE SCREW WAS IN THE PEDICLE, THE STYLET BENT MAKING IT HARD TO BACK OUT THE DRIVER. THE SURGEON THEN USED MALLET FORCE ON THE BLACK T-HANDLE TO KNOCK IT OUT AND SNAPPED THE HANDLE INTO THREE PART. NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HANDLE. NO SURGICAL DELAY WAS REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN DISTRACTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10413092 ↗