VIPER PRIME 286750036Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705034507637), received between Feb 2, 2021 and Jan 15, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Device-Device Incompatibility; Material Deformation

  PATIENT UNDERWENT MIS DEGENERATIVE CASE. DURING ASSEMBLY OF THE VIPER PRIME NAVIGATED SCREWDRIVER, THE SCRUB NURSE NOTED THAT THE END CAP OF THE PALM HANDLE WAS DEFORMED IN SUCH A WAY THAT THE STYLET HOLDER COULD NOT BE INSERTED THROUGH THE PALM HANDLE. ALL HANDLES ARE DEFORMED. IT SEEMS THAT STRIKING THE CAPS ON THE HANDLES CAUSES THEM TO DEFORM, EVEN THOUGH THESE CAPS ARE SPECIFICALLY DESIGNED FOR THIS PURPOSE. SURGERY COULD BE COMPLETED BY CHANGING THE ASSEMBLY SEQUENCE, SO NO ISSUED OCCURRED DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083588 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility; Material Deformation

  PATIENT UNDERWENT MIS DEGENERATIVE CASE. DURING ASSEMBLY OF THE VIPER PRIME NAVIGATED SCREWDRIVER, THE SCRUB NURSE NOTED THAT THE END CAP OF THE PALM HANDLE WAS DEFORMED IN SUCH A WAY THAT THE STYLET HOLDER COULD NOT BE INSERTED THROUGH THE PALM HANDLE. ALL HANDLES ARE DEFORMED. IT SEEMS THAT STRIKING THE CAPS ON THE HANDLES CAUSES THEM TO DEFORM, EVEN THOUGH THESE CAPS ARE SPECIFICALLY DESIGNED FOR THIS PURPOSE. SURGERY COULD BE COMPLETED BY CHANGING THE ASSEMBLY SEQUENCE, SO NO ISSUED OCCURRED DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083582 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility; Material Deformation

  PATIENT UNDERWENT MIS DEGENERATIVE CASE. DURING ASSEMBLY OF THE VIPER PRIME NAVIGATED SCREWDRIVER, THE SCRUB NURSE NOTED THAT THE END CAP OF THE PALM HANDLE WAS DEFORMED IN SUCH A WAY THAT THE STYLET HOLDER COULD NOT BE INSERTED THROUGH THE PALM HANDLE. ALL HANDLES ARE DEFORMED. IT SEEMS THAT STRIKING THE CAPS ON THE HANDLES CAUSES THEM TO DEFORM, EVEN THOUGH THESE CAPS ARE SPECIFICALLY DESIGNED FOR THIS PURPOSE. SURGERY COULD BE COMPLETED BY CHANGING THE ASSEMBLY SEQUENCE, SO NO ISSUED OCCURRED DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083562 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility; Material Deformation

  PATIENT UNDERWENT MIS DEGENERATIVE CASE. DURING ASSEMBLY OF THE VIPER PRIME NAVIGATED SCREWDRIVER, THE SCRUB NURSE NOTED THAT THE END CAP OF THE PALM HANDLE WAS DEFORMED IN SUCH A WAY THAT THE STYLET HOLDER COULD NOT BE INSERTED THROUGH THE PALM HANDLE. ALL HANDLES ARE DEFORMED. IT SEEMS THAT STRIKING THE CAPS ON THE HANDLES CAUSES THEM TO DEFORM, EVEN THOUGH THESE CAPS ARE SPECIFICALLY DESIGNED FOR THIS PURPOSE. SURGERY COULD BE COMPLETED BY CHANGING THE ASSEMBLY SEQUENCE, SO NO ISSUED OCCURRED DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083559 ↗
• MalfunctionDec 19, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED WHILE PREPARING FOR OUR SURGERY, IT WAS DISCOVERED THAT THE FINAL TIGHTENER WAS STRIPPED, AND THE HANDLE NO LONGER FIT PROPERLY INTO THE SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849049 ↗
• MalfunctionDec 19, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE PROVIDE THE LOT NUMBER OF THE REPORTED DEVICES. I DON¿T HAVE A LOT NUMBER FOR THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849022 ↗
• MalfunctionDec 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WHEN NURSE WAS SETTING UP VIPER PRIME SCREWDRIVERS WITH PALM HANDLES ANG GAUGES, IT WAS NOTICED THAT THE HANDLES ARE DAMAGED WHERE THE GAUGE FITS IN. THE TOP OF THE HANDLES ARE IMPACTED WHERE THE GAUGE NO LONGER SCREWS IN. THEREFORE THE NURSE HAD TO CHANGE THE HANDLES. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859626 ↗
• MalfunctionDec 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WHEN NURSE WAS SETTING UP VIPER PRIME SCREWDRIVERS WITH PALM HANDLES ANG GAUGES, IT WAS NOTICED THAT THE HANDLES ARE DAMAGED WHERE THE GAUGE FITS IN. THE TOP OF THE HANDLES ARE IMPACTED WHERE THE GAUGE NO LONGER SCREWS IN. THEREFORE THE NURSE HAD TO CHANGE THE HANDLES. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856502 ↗
• MalfunctionDec 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED DURING A SPINAL FUSION PROCEDURE ON (B)(6), 2023, THE NURSE WAS HAVING DIFFICULTIES INSERTING AND REMOVING THE GAUGE WITH STYLET THROUGH THE PALM HANDLES. THE TOP OF THE HANDLES ARE LIKELY TO BE DAMAGED FROM THE MALLET. THE HANDLE APPEARED DAMAGED WHERE THERE IS A SILVER RING WHERE THE INNER STYLET FITS IN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE T HANDLES FOUND IN THE SET. NO SURGICAL DELAY OR PATIENT IMPACT. THIS REPORT IS FOR VIPER PRIME PALM HANDLE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384519 ↗
• MalfunctionDec 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2023, THE NURSE WAS HAVING DIFFICULTIES INSERTING AND REMOVING THE GAUGE WITH STYLET THROUGH THE PALM HANDLES. THE TOP OF THE HANDLES ARE LIKELY TO BE DAMAGED FROM THE MALLET. THE HANDLE APPEARED DAMAGED WHERE THERE IS A SILVER RING WHERE THE INNER STYLET FITS IN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE T HANDLES FOUND IN THE SET. NO SURGICAL DELAY OR PATIENT IMPACT. THIS REPORT IS FOR VIPER PRIME PALM HANDLE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384480 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2023, THE NURSE WAS HAVING ISSUES REMOVING THE GAUGED PART FROM THE TWO PALM HANDLES, GIVEN THEIR WEAR AND TEAR AS A RESULT OF THE SURGEON MALLETING THE HANDLES. THERE WAS DAMAGE TO THE TOP OF THE HANDLE, WHERE THE INNER GAUGE SCREWS IN IMPROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE VIPER PRIME PALM HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906380 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2023, THE NURSE WAS HAVING ISSUES REMOVING THE GAUGED PART FROM THE TWO PALM HANDLES, GIVEN THEIR WEAR AND TEAR AS A RESULT OF THE SURGEON MALLETING THE HANDLES. THERE WAS DAMAGE TO THE TOP OF THE HANDLE, WHERE THE INNER GAUGE SCREWS IN IMPROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE VIPER PRIME PALM HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906374 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NOTICED THAT THE PALM HANDLES WERE DAMAGED ON THE TOP. ONCE THE HANDLE WAS INSERTED, THE GAUGE COULD NOT BE EASILY INSERTED DUE TO THE DAMAGED METAL ON THE TOP OF THE PALM HANDLE. ALSO, THE TARGETING FORCEPS WERE OLD AND DAMAGED AT THE TIP, WHERE THE BLACK RUBBER MATERIAL IS WEARING OFF AND STARTING TO PEEL. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THESE EVENTS. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME PALM HANDLE. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617028 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NOTICED THAT THE PALM HANDLES WERE DAMAGED ON THE TOP. ONCE THE HANDLE WAS INSERTED, THE GAUGE COULD NOT BE EASILY INSERTED DUE TO THE DAMAGED METAL ON THE TOP OF THE PALM HANDLE. ALSO, THE TARGETING FORCEPS WERE OLD AND DAMAGED AT THE TIP, WHERE THE BLACK RUBBER MATERIAL IS WEARING OFF AND STARTING TO PEEL. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THESE EVENTS. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME PALM HANDLE. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617025 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NOTICED THAT THE PALM HANDLES WERE DAMAGED ON THE TOP. ONCE THE HANDLE WAS INSERTED, THE GAUGE COULD NOT BE EASILY INSERTED DUE TO THE DAMAGED METAL ON THE TOP OF THE PALM HANDLE. ALSO, THE TARGETING FORCEPS WERE OLD AND DAMAGED AT THE TIP, WHERE THE BLACK RUBBER MATERIAL IS WEARING OFF AND STARTING TO PEEL. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THESE EVENTS. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME PALM HANDLE. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617009 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NOTICED THAT THE PALM HANDLES WERE DAMAGED ON THE TOP. ONCE THE HANDLE WAS INSERTED, THE GAUGE COULD NOT BE EASILY INSERTED DUE TO THE DAMAGED METAL ON THE TOP OF THE PALM HANDLE. ALSO, THE TARGETING FORCEPS WERE OLD AND DAMAGED AT THE TIP, WHERE THE BLACK RUBBER MATERIAL IS WEARING OFF AND STARTING TO PEEL. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THESE EVENTS. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME PALM HANDLE. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616965 ↗
• MalfunctionApr 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT IT WAS DIFFICULT TO SCREW THE GAUGE INSIDE THE HANDLE WHILE SETTING UP FOR THE STYLET INSIDE THE GAUGE WHICH THEN GOES INTO THE HANDLE. ACCORDING TO THE REPORT, THE SILVER LINING OF THE HANDLES WERE DAMAGED, CAUSING DIFFICULTY TO SCREW THE GAUGE OF THE STYLET INSIDE. THERE WAS NO DELAY AS WE FOUND THIS OUT DURING THE SETUP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VIPER PRIME PALM HANDLE DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253644 ↗
• MalfunctionApr 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN CANADA THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT IT WAS DIFFICULT TO SCREW THE GAUGE INSIDE THE HANDLE WHILE SETTING UP FOR THE STYLET INSIDE THE GAUGE WHICH THEN GOES INTO THE HANDLE. ACCORDING TO THE REPORT, THE SILVER LINING OF THE HANDLES WERE DAMAGED, CAUSING DIFFICULTY TO SCREW THE GAUGE OF THE STYLET INSIDE. THERE WAS NO DELAY AS WE FOUND THIS OUT DURING THE SETUP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VIPER PRIME PALM HANDLE DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253613 ↗
• MalfunctionApr 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN CANADA THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT IT WAS DIFFICULT TO SCREW THE GAUGE INSIDE THE HANDLE WHILE SETTING UP FOR THE STYLET INSIDE THE GAUGE WHICH THEN GOES INTO THE HANDLE. ACCORDING TO THE REPORT, THE SILVER LINING OF THE HANDLES WERE DAMAGED, CAUSING DIFFICULTY TO SCREW THE GAUGE OF THE STYLET INSIDE. THERE WAS NO DELAY AS WE FOUND THIS OUT DURING THE SETUP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VIPER PRIME PALM HANDLE DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253606 ↗
• MalfunctionApr 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE HANDLE FROM THE DRIVER WAS DAMAGED THAT THE HANDLE WAS NOT ABLE TO BE PLACED ON THE SCREWDRIVER. IT WAS FURTHER REPORTED THAT THE STYLET DEPTH ADJUSTER END RING WAS DAMAGED AND COMPLETELY CAME OFF WHILE TRYING TO REMOVE THE BENT STYLET FROM THE SCREWDRIVER. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VIPER PRIME PALM HANDLE DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137321 ↗
• MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A POSTERIOR SPINAL FUSION PROCEDURE, THE VIPER PRIME HANDLE COULD NOT ASSEMBLE WITH THE UNKNOWN STYLET ATTACHMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE FROM THE SET. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME PALM HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13077951 ↗
• MalfunctionFeb 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SURGEON PERFORMED A HYBRID CONSTRUCT USING THE VIPER PRIME AND THE EXPEDIUM 5.5MM SYSTEM. THE PATIENT HAD HARD BONE AND GIVEN THIS FACT, THE PALM HANDLE FOR THE VIPER PRIME SCREWDRIVER WAS SIGNIFICANTLY DAMAGED DUE TO THE USE OF A HAMMER. THIS HANDLE NO LONGER ATTACHES TO THE PRIME SCREWDRIVER AND THEREFORE NEEDS TO BE REPLACED. ALSO, WITH THE EXPEDIUM SYSTEM, THE BALL TIP FEELER STRAIGHT WAS BENT, AND THE TORQUE DRIVE SHAFT WAS STRIPPED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN HAMMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ), UNKNOWN PRIME SCREWDRIVER(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME PALM HANDLE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11265283 ↗