VIPER 279726400Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034199481), received between Jul 13, 2017 and Dec 7, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  PROCEDURE WAS COMPLETED SUCCESSFULLY USING OTHER ALIGNMENT DEVICES. PATIENT IS RECOVERING AS EXPECTED. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952922 ↗
• MalfunctionSep 29, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, INTRAOPERATIVELY IT WAS NOTICED THAT THE TIP OF THE INSTRUMENT WAS BENT. AS A RESULT NO SINGLE DISPOSABLE CEMENT CANNULA CAN BE USED. NO ALLEGATION AGAINST ITEM. SURGERY WAS COMPLETED SUCCESSFULLY. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE SURGERY WITHOUT ANY PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: CEMENT CANNULA (PART# 279726508, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER SYSTEM ALIGNMENT DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12549981 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE POST-DELIVERY CHECK OF THE INSTRUMENTS FOR PERMEABILITY, IT WAS FOUND THAT THE LOWER OPENING WAS SMALL AND IT WAS NOT POSSIBLE TO INSERT THE MINI CLEANING HANDLELET. CLEANING OF THE METAL SLEEVE WAS NOT POSSIBLE WITH THE CLEANING STYLET. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM ALIGNMENT DEVICE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893239 ↗
• MalfunctionSep 16, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE, THE TIP OF THE MISALIGNMENT DEVICE WAS MALFORMED. THE DEVICE MISSED ITS TARGET HOLE IN THE IMPLANT AND THE CLINICIAN ATTEMPTED TO TIGHTEN IT. AFTER USING AN UNKNOWN NEEDLE TO TEST IF THE TIP OF THE MISALIGNMENT DEVICE WAS CLEAR, IT WAS OBSERVED THAT THE NEEDLE COULD NOT GO THROUGH THE TIP AND THE TIP WAS DAMAGED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. THIS REPORT IS FOR ONE (1) MIS ALIGNMENT DEVICE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540412 ↗
• MalfunctionJul 10, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THREADING IN THE ALIGNMENT GUIDE, IT WOULD NOT GO ALL THE WAY DOWN TO ALIGN WITH THE SCREW SHANK BECAUSE OF SCREW EXTENSION CROWDING. THE SURGEON TRIED TO USE THE WRENCH TO FORCE IT DOWN AND THE TIP OF THE ALIGNMENT GUIDE FRACTURED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777053 ↗
• MalfunctionJul 13, 2017Torn Material; Torn Material

  REPORTED BY COMMERCIAL COORDINATOR IN (B)(6). WE HAVE ALSO PRODUCT COMPLAINTS IN DC DEPUY (ORTHOKIT/LOANER SITE) FOR 2017 YEAR. DEVICES QUARANTINED DUE TO BREAKAGES, FUNCTIONAL TESTS FAILURES. IN ALL CASES NO DATA AVAILABLE IF ANY INJURES OR ADVERSE EVENTS. NO INFORMATION ABOUT SURGERY, DELAYS, PATIENT RELATED DATA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6711837 ↗