VIPER 286705320Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034507859), received between Apr 17, 2018 and Apr 11, 2023 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HONG KONG AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE EVENT OCCURRED DURING OPERATION. AFTER INSERTION OF THE LEFT SACRO-ILIAC SCREW UNDER THE COMPUTER NAVIGATION GUIDE, X-RAY SCREENING NOTED A SMALL BROKEN TIP OF THE GUIDE PIN JUST DISTAL TO THE SCREW TIP. MEASUREMENT OF THE GUIDE PIN SHOWED LOSS OF TIP OF GUIDE PIN BY 7MM. INTRAOPERATIVE DECISION NOT TO REMOVE THE RETAINED GUIDE PIN TIP BECAUSE THERE IS NO EFFECT ON THE PATIENT AND THE TECHNICAL DIFFICULTY OF REMOVAL THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT 1.45MM NITINOL GUIDEWIRE BLUNT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16717122 ↗
• InjuryMar 8, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE SURGEON WAS PERFORMING AN L4/5 AND L5/S1 INSTRUMENTED FUSION WITH INTERBODY FUSIONS. THE SURGEON INSERTED A NON-SYNTHES NEEDLE FOLLOWED BY A SYNTHES GUIDEWIRE. IT WAS NOTED ON IMAGING THAT A PIECE OF THE GUIDEWIRE HAD BROKEN OFF INTO THE VERTEBRAL BODY. THE BROKEN MATERIAL REMAINED IN-SITU AND ALL IMPLANTS WERE SUCCESSFULLY IMPLANTED AND THE PROCEDURE COMPLETED. THERE WAS NO DELAY TO SURGERY. THIS REPORT INVOLVES ONE VIPER SYSTEM NITINOL GUIDEWIRE, BLUNT AND DISPOSABLE 1.45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16501534 ↗
• InjuryDec 15, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A L2-SAI POSTERIOR INSTRUMENTED FUSION AT CAIRNS PRIVATE ON THE (B)(6) 2022 ON PATIENT. A GUIDEWIRE WAS INSERTED SO THAT IT COULD GUIDE THE S1 SCREW BUT UNFORTUNATELY THE TIP OF THE GUIDEWIRE BROKE INSIDE THE PATIENT. THE BROKEN TIP REMAINED INSITU IN THE VERTEBRAL BODY BUT WILL NEED TO CONFIRM THIS. CONSTRUCT WAS EXTENDED TO S2 WITH AN SAI SCREW ON BOTH THE LEFT AND RIGHT SIDE. ACTION TAKEN WHEN EVENT OCCURRED? CONSTRUCT WAS EXTENDED TO S2 WITH AN SAI SCREW ON BOTH THE LEFT AND RIGHT SIDE. FRAGMENTS WERE GENERATED BUT IS UNKNOWN IF THE TIP WAS RETAINED IN THE BODY. IS UNKNOWN IS PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 1.45MM NITINOL GUIDEWIRE BLUNT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15991085 ↗
• InjuryDec 12, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2022, THAT DURING SPINAL FUSION PROCEDURE PIECE OF K-WIRE BROKE OFF IN VERTEBRAL BODY DURING MIS TLIF PROCEDURE WHEN SURGEON WAS INSERTING SCREWS AND TRIED TO REMOVE THE WIRE. APPROXIMATELY 2MM OF K-WIRE WAS LEFT IN THE VERTEBRAL BODY IN THE LUMBAR REGION. SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART#: UNKNOWN; LOT#: UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 1.45MM NITINOL GUIDEWIRE BLUNT. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15958793 ↗
• MalfunctionOct 18, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON TRIED TO PUT THE SCREW THROUGH THE GUIDEWIRE, IT STUCK. THE TIP OF THE GUIDEWIRE BROKE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM NITINOL GUIDEWIRE, BLUNT AND DISPOSABLE 1.45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623787 ↗
• InjuryApr 7, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING SPINAL FUSION SURGERY, A PIECE OF A GUIDE WIRE BROKE OFF WHILE PLACING A SCREW AND STAYED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE FRAGMENTS COULD NOT BE REMOVED EASILY BY THE SURGEON AS THERE WAS NO WAY TO RETRIEVE IT. THERE WAS NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 1.45MM NITINOL GUIDEWIRE BLUNT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14047369 ↗
• InjuryDec 23, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, WHILE TAPPING A PEDICLE DURING AN MIS CASE, THE GUIDEWIRE WAS UP AGAINST THE ENDPLATE. THE SURGEON FOLLOWED THE NITINOL GUIDEWIRE WITH A 6.0 TAP AND THE TIP OF THE TAP CUT THROUGH THE DISTAL TIP OF THE GUIDEWIRE AS IT ENGAGED THE ENDPLATE. THE TAP WAS REMOVED, AND THE SCREW WAS INSERTED. THEN THE GUIDEWIRE WAS REMOVED, AND IT WAS NOTED THAT THERE WAS A SMALL FRAGMENT OF THE GUIDEWIRE IN THE VERTEBRAL BODY. GUIDEWIRE REMOVED FROM FIELD, NO FURTHER ISSUES. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED. UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN ENDPLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 1.45MM NITINOL GUIDEWIRE BLUNT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13080314 ↗
• InjuryDec 10, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE PROCEDURE WHILE THE PEDICLE PREPARING FOR A PERCUTANEOUS SCREW, THE DISTAL TIP OF A NITINOL GUIDEWIRE WAS BROKEN OFF IN THE VERTEBRAL BODY. THE PORTION OF THE GUIDEWIRE COULD NOT BE RETRIEVED. SURGICAL DELAY IS UNKNOWN. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CANNULATED GEARSHIFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN PERCUTANEOUS SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 1.45MM NITINOL GUIDEWIRE BLUNT. THIS IS REPORT 1 OF 1 OR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12975480 ↗
• MalfunctionMay 23, 2018Break; Break

  TIP OF WIRE BROKE OFF WHILE REMOVING AND A 2 CM FRAGMENT REMAINED IN THE VERTEBRAL BODY OF PATIENT.

  Patient problems: Local Reaction; No Consequences Or Impact To Patient

  MAUDE report 7537284 ↗
• MalfunctionApr 17, 2018Break; Break

  SURGEON DID THE SAI SCREW VIA GUIDE WIRE. SURGEON HAVE DIFFICULTY TO REMOVE THE GUIDEWIRE AFTER SCREW INSERTION. WHILE SURGEON TRY TO REMOVE IT, THE GUIDEWIRE WAS BROKEN INSIDE PATIENT. (CUSTOMER HAS CONCERN ABOUT THE BIO-COMPATIBILITY OF THE BROKEN PIECE OF GUIDEWIRE INSIDE PATIENT. PLEASE PROVIDE INFORMATION ASAP.) PATIENT CONSEQUENCE? UNKNOWN. PATIENT CONSEQUENCE DESCRIPTION:BROKEN PIECE OF GUIDEWIRE (AROUND 4 MM) LEFT INSIDE PATIENT. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Foreign Body Reaction

  MAUDE report 7435627 ↗