VIPER 286735350Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034214573), received between Aug 16, 2017 and Aug 12, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227988 ↗
• MalfunctionAug 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON AN UNKNOWN DATE. DURING SURGERY, THE SURGEON ATTEMPTED TO PLACE A SET SCREW, BUT WAS UNABLE TO GRASP THE SET SCREW WITH THE TIP OF THE SET SCREW INSERTER, AND THE SET SCREW QUICKLY CAME OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748715 ↗
• MalfunctionFeb 8, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 , THAT THE INNIE DRIVER TIP BROKE WHEN THE SURGEONS WAS EXERTING STRENGTH TO DRIVE THE INNIE. ONE PIECE OF THE FRAGMENTED PART WAS RETRIEVED OUT FROM PATIENT BODY. THE BROKEN DRIVER AND TIP WAS DISPOSED AS IT WAS COVERED WITH BLOOD. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VIPER2 X25 APPROXIMATING SET S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325883 ↗
• MalfunctionMar 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING AN INCOMING INSPECTION IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAS BROKEN OFF. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT ARE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) VIPER2 X25 APPROXIMATING SET S. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440849 ↗
• MalfunctionAug 16, 2017Break; Break

  ORTHOKIT SPECIALIST CHECKED DEVICES AND FOUND NEXT DAMAGES: CODE 286720000 - THE THREAD DAMAGE CODE 286735350 - HAD THE WORKING PART OF THE SCREWDRIVER CODE 286735400 - THE FAILURE OF THE SLOT CODE 286745550 - THE WORKING PART WAS BROKEN. THE DATE OF INSPECTION IS (B)(6) 2017 AND WE ACCEPTED THIS DATE AS DATE OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6798145 ↗