Veptr 03.641.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034720111), received between Jan 3, 2017 and Dec 27, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE STAR SCREWDRIVER FROM THE VEPTR II TRAY WAS BROKEN AND REQUIRED REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VEPTR NUT DRIVER SHAFT 6MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050576 ↗
• MalfunctionOct 22, 2019Device-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, THE NUT DRIVER SHAFT WAS STICKING WHEN ENGAGING. THE TIP OF THE INNER PIN IS BENT AND CAN PREVENT ALIGNMENT. IT WAS MENTIONED THAT THE DEVICE WAS USED FIVE (5) TIMES HAPPENED IN 2018 DURING CASES. THERE WAS A FEW MINUTES DEALT WHILE THEY ALIGNED IT. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) WHICH CAPTURES THE VEPTR NUT DRIVER SHAFT WAS NOTICED THAT TIP WAS BENT AND THE FOLLOWING COMPLAINTS (B)(4) CAPTURE THE INTRAOPERATIVE USAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217978 ↗
• MalfunctionOct 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THIS COMPLAINT IS LINKED TO THIS (B)(4). AS IT CAPTURES THE 4TH COMPLAINT OF THE VEPTR NUT DRIVER SHAFT 6 THAT WAS USED OUT OF FIVE (5) TIMES HAPPENED IN 2018 DURING CASES. ALL PRODUCT COMPLAINT FOLLOW UP WILL BE CAPTURED UNDER (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217910 ↗
• MalfunctionOct 22, 2019Device-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, THE NUT DRIVER SHAFT WAS STICKING WHEN ENGAGING. THE TIP OF THE INNER PIN IS BENT AND CAN PREVENT ALIGNMENT. IT WAS MENTIONED THAT THE DEVICE WAS USED FIVE (5) TIMES HAPPENED IN 2018 DURING CASES. THERE WAS A FEW MINUTES DEALT WHILE THEY ALIGNED IT. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) WHICH CAPTURES THE VEPTR NUT DRIVER SHAFT WAS NOTICED THAT TIP WAS BENT AND THE FOLLOWING COMPLAINTS (B)(4) CAPTURE THE INTRAOPERATIVE USAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217867 ↗
• MalfunctionOct 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOW. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE NUT DRIVER SHAFT WAS CATCHING AND STICKING WHEN ENGAGING. THE TIP OF THE INNER PIN IS BENT AND PREVENTS ALIGNMENT. THIS HAPPENED FIVE (5) TIMES IN 2018 DURING CASES. THERE WAS A FEW MINUTES DELAY WHILE THEY ALIGNED IT. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) VEPTR NUT DRIVER SHAFT 6. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Code Available

  MAUDE report 9214773 ↗
• MalfunctionOct 18, 2019Device-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, THE NUT DRIVER SHAFT WAS CATCHING / STICKING WHEN ENGAGING, TIP OF THE INNER PIN IS BENT AND CAN PREVENT ALIGNMENT. IT WAS MENTIONED THAT THE SALES CONSULTANT WASN'T PRESENT AT THE CASE, BUT IT WAS USED FIVE (5) TIMES HAPPENED IN 2018 DURING CASES AND WAS CATCHING/STICKING WHEN ENGAGING. THERE WERE 9 MINUTES DEALT WHILE THEY ALIGNED IT. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT HARMS. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208641 ↗
• MalfunctionSep 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AUGUST 14, 2019, THE TRAY WAS OPENED FOR TRAINING AND NOTICED THE TIP WAS BENT. THERE WERE ISSUES DURING THE LAST CASE OF IT NOT ENGAGING STRAIGHT AWAY. WHEN IT WAS EXAMINED IT IS CLEARLY SLIGHTLY BENT. INSTRUMENT HAS BEEN ON THE SET FOR FIVE YEARS. THE INSTRUMENT ENGAGED IN THE END WHICH TOOK THE SURGEON A FEW MOMENTS LONGER. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) VEPTR NUT DRIVER SHAFT6 MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9008983 ↗
• MalfunctionJan 3, 2017Bent; Break; Bent; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, DURING SURGERY IT WAS DETECTED THAT THE VEPTR NUT DRIVER SHAFT WAS BENT/BROKEN. THE TIP OF THE INSTRUMENT WAS BENT. THE SURGERY WAS NOT PROLONGED. THE VEPTR NUT DRIVER SHAFT WAS ALREADY BENT/BROKEN BEFORE THE SURGERY. IT WAS DETECTED DURING SURGERY. NO BROKEN FRAGMENTS WERE GENERATED. NO PATIENT HARM WAS REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THIS REPORT IS FOR ONE (1) VEPTR NUT DRIVER SHAFT 6 MM HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6218786 ↗