VIPER 286735200Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705034214542), received between Dec 15, 2017 and Jun 18, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Break

  IT WAS REPORTED TWO INSTRUMENTS BROKE DURING A PROCEDURE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A FIVE MINUTE DELAY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25551626 ↗
• MalfunctionNov 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 6, 2023, THE TIP OF THE TOOL WAS NOTED TO BE BROKEN OFF. IT IS UNKNOWN WHEN THE EVENT OCCURRED. IT WAS REPORTED THAT THERE WAS NO EXTENSION OF SURGICAL TIME, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD HOLDER, ADVANCED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220790 ↗
• MalfunctionAug 24, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AT THE TIME OF ASSEMBLING THE BAR IN THE BAR HOLDER, IT WAS EVIDENT THAT IT NEEDED THE INTERNAL SCREW THAT TIGHTENS THE BAR; HOWEVER, THE FOUR ADDITIONAL BAR HOLDERS IN THE EQUIPMENT DID NOT HAVE THE INTERNAL SCREW, AND THEREFORE THEY COULD NOT BE USED. THE SURGEON SOUGHT A SOLUTION TO BE ABLE TO PLACE THE BAR, AND WAS ABLE TO COMPLETE THE SURGERY IN AN APPROPRIATE WAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF ONE HOUR. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD HOLDER, ADVANCED. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610264 ↗
• MalfunctionAug 21, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AT THE TIME OF ASSEMBLE THE BAR IN THE BAR HOLDER EVIDENCED THAT IT NEEDS THE INTERNAL SCREW THAT TIGHTENS THE BAR HOWEVER INSIDE THE TEAM I HAVE 4 MORE BAR HOLDER, BUT NONE OF THE AVAILABLE CABLE CARRIERS HAD THE INTERNAL SCREW AND THEREFORE COULD NOT BE USED, HE WARNED THE SURGEON AND AT THAT TIME HE SOUGHT A SOLUTION TO BE ABLE TO PLACE THE BAR. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ONE(1) HOUR OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM ROD HOLDER, ADVANCED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583586 ↗
• MalfunctionJul 27, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT ONE PIECE OF THE ARTICLE, THE EXP VIPER2 ROD HOLDER FOR RODS OVER 100, HAD A BROKEN HANDLE. THERE WAS PATIENT INVOLVEMENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM NO SURGERY DELAY. THIS REPORT IS FOR ONE (1) VIPER2 ROD HOLDER, ADVANCED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406990 ↗
• MalfunctionJul 11, 2023Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE HANDLE OF THE INSTRUMENT IN QUESTION FRACTURED. THE INSTRUMENT FRACTURED IN THE MIDDLE INTO MULTIPLE PARTS, BUT NO FRAGMENT ENTERED THE SURGICAL AREA. THERE WAS NO SURGICAL DELAY REPORTED. NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM ROD HOLDER, ADVANCED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297260 ↗
• MalfunctionMar 8, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A PERCUTANEOUS PEDICLE SCREW PROCEDURE (L2 TO L5) FOR SPINAL STENOSIS. WHEN THE ROD HOLDER WAS REMOVED AFTER ROD ATTACHMENT, THE ROD HOLDER BROKE. IT WAS FOUND THAT THE CONNECTION PART WAS BROKEN OFF, AND THERE WERE FRAGMENTS. THE FRAGMENTS WERE REMOVED FROM THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE DELAY. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD HOLDER, ADVANCED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501776 ↗
• MalfunctionJan 19, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE EVENT OCCURRED DURING AN ANTERIOR-POSTERIOR LUMBAR SPINAL FUSION (L2 TO L5) FOR THE LSCS. THE EVENT TOOK PLACE IN SEQUENCE AS FOLLOWS: 1. THREE INTERVERTEBRAL OLIF WAS PERFORMED WITH THE MEDTRONIC CAGE. 2. THE POSITION CHANGED TO POSTERIOR PRONE, AND EIGHT VIPER SYSTEM SCREWS WERE INSERTED BETWEEN THE THREE INTERVERTEBRAL FROM L2 TO L5. 3. THE ROD WAS GRIPPED BY THE ROD HOLDER, AND ROD INSTALLED FROM HEAD SIDE TO SCREW HEAD. SET SCREWS WERE INSTALLED IN SEQUENCE FROM L5 TO HEAD SIDE WITH CANTILEVER METHOD WHILE GRIPPING THE ROD WITH THE ROD HOLDER. 4. WHEN THE SURGEON WAS TIGHTENING THE SET SCREW WHILE PRESSING DOWN ON THE ROD HOLDER, THE SURGEON FELT STRANGE WITH THE ROD HOLDER. IT WAS FOUND THAT THE TIP OF THE ROD HOLDER WAS BROKEN. 5. THE ROD HOLDER WAS BROKEN NEAR THE TIP, AND THE DAMAGED PART WAS CONNECTED TO THE ROD. THEREFORE, THE ENTIRE ROD WAS REMOVED FROM THE BODY. 6. OTHER INSTRUMENT WAS USED INSTEAD OF THE ROD HOLDER IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. ACCORDING TO THE SURGEON, HE DID NOT USE STRONG FORCE OR FORCEFUL OPERATION. NO FURTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16207720 ↗
• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 FOUND THIS BROKEN VIPER 2 ROD HOLDER, ADVANCED WITH THE TIP OF THE ROD HOLDER BROKEN. UNKNOWN AS TO HOW IT HAPPENED, I FOUND IT IN CPD, IT WAS SEPARATED FROM THE KIT, SITTING ALONE ON TOP OF MY LOOSE EQUIPMENT. IT HAS BEEN DECONTAMINATED AND CLEANED, IT WILL NOT BE REPROCESSED FOR USE AND CAN BE RETURNED BUT NEEDS TO BE REPLACED. THIS DID NOT HAPPEN WHEN I WAS AROUND, I SIMPLY FOUND IT IN THIS CONDITION. NO PATIENT CONSEQUENCE . THIS REPORT IS FOR ONE (1) VIPER2 ROD HOLDER, ADVANCED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751880 ↗
• MalfunctionJul 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT EVENT DESCRIPTION OF COMPLAINT HANDLE ON ROD INSERTER BROKE DURING USE. THERE WAS NO SURGERY DELAY DUE TO THE EVENT . A SAME LIKE PRODUCT WAS USED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) VIPER2 ROD HOLDER, ADVANCED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14985904 ↗
• MalfunctionMar 19, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A & P LUMBAR FUSION SURGERY WHEN PASSING THE ROD ON A T10 - PELVIS CONSTRUCT, THE PART WHERE THE ROD ENGAGES WITH THE ROD HOLDER BROKE. THE SURGEON WAS ABLE TO ATTACH ANOTHER ROD HOLDER AND DID NOT SEE ANY FRAGMENTS GENERATED. THEY PASSED THE BROKEN ROD HOLDER OFF THE FIELD AND IT IS NOT IN USE ANYMORE. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828104 ↗
• MalfunctionFeb 23, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE HANDLE OF THE VIPER 2 ADVANCED ROD HOLDER BROKE AFTER ROD MIS INSERTION AT THE RETRIEVAL TIME. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM ROD HOLDER, ADVANCED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587025 ↗
• MalfunctionAug 13, 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 INTERBODY FUSION (TH10-S2) SURGERY FOR TREATING ASD. DURING THE SURGERY, WHILE ROD WAS BEING DEPLOYED, THE ROD HOLDER WAS BROKE. THE SURGERY WAS COMPLETED WITHOUT DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: MATRIXRIB (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) VIPER2 ROD HOLDER, ADVANCED. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321235 ↗
• MalfunctionAug 5, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE GREEN HANDLE OF THE VIPER 2 SYSTEM ROD HOLDER, ADVANCED HAS BROKEN OFF. NO FRAGMENTS WERE GENERATED AND SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE INSTRUMENT. THERE WAS NO SURGICAL DELAY AND NO ADVERSE PATIENT HARM. PATIENT OUTCOME WAS GOOD, AS INTENDED. THIS REPORT IS FOR ONE (1) VIPER2 ROD HOLDER, ADVANCED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12282428 ↗
• MalfunctionJul 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED A ROD HOLDER HAD SOMETHING BROKEN OFF AND STUCK IN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE INSTRUMENT. NO SURGICAL DELAY WAS REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR A ROD HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150859 ↗
• MalfunctionApr 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT DURING AN UNKNOWN SURGERY, THE INNER CAPTURE PIECE OF ROD HOLDER MALFUNCTIONED CAUSING THE ROD TO NOT BE PROPERLY CAPTURED. ANOTHER ROD HOLDER WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS NO REPORTED SURGICAL DELAY. THERE WAS NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: ROD (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) VIPER2 ROD HOLDER, ADVANCED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10006504 ↗
• MalfunctionJun 25, 2019Break; Break

  IT WAS REPORTED THAT AN UNKNOWN DATE, DURING UNKNOWN PROCEDURE, THE SURGEON WAS REDUCING THE ROD AND SIMULTANEOUSLY TRYING TO PULL THE ROD BACK. WHILE MANIPULATING THE ROD HOLDER IT SNAPPED. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. THERE WAS NO PATIENT HARM/CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8730609 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE WHEN LEVERAGING UP ON THE ROD HOLDER DURING A LONG CONSTRUCT CASE, THE TIP OF THE ROD HOLDER SNAPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND SURGICAL DELAY IS UNKNOWN. PATIENT INVOLVEMENT IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689778 ↗
• MalfunctionDec 15, 2017Fracture; Fracture

  VIPER MIS ROD HOLDER BROKE. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121318 ↗