Veptr 03.641.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10705034720128), received between Aug 13, 2019 and Apr 28, 2026 — classified as 86 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (79 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 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Calibration Problem

  IT WAS REPORTED THAT THE TORQUE TESTING FAILED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017612 ↗
• MalfunctionOct 16, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ITEM DID NOT PASS TORQUE TEST INSPECTION. THE TORQUE TEST RESULT IS OUT OF LIMITS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466030 ↗
• MalfunctionOct 11, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING INSPECTION ON (B)(6) 2024, TWO SOCKET WRENCHES DID NOT PASS THE TORQUE TEST. THIS REPORT IS FOR A SOCKET WRENCH FOR VEPTR NUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429213 ↗
• MalfunctionSep 24, 2024Calibration Problem; Calibration Problem

  DURING TODAY¿S INSPECTION, TORQUE TEST DIDN¿T PASS. THE TORQUE TEST WAS NOT WITHIN CORRECT RANGE ON THIS ITEM. THE RANGE SHOULD BE 5,00- 6,40. THIS REPORT INVOLVES ONE SOCKET WRENCH FOR VEPTR NUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291380 ↗
• MalfunctionAug 29, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AUGUST 1, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT HOSPITAL, IT WAS OBSERVED THAT HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20098639 ↗
• MalfunctionAug 26, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6), 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE N.M HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION OF THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071711 ↗
• MalfunctionFeb 8, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE SITE, IT WAS OBSERVED THAT MATERIAL 03.641.004, SOCKET WRENCH FOR VEPTR NUT, SN J001347-06 WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 5.0 ¿ 6.4 NM. THE TORQUE TESTED HIGH ¿ 10.61 NM. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED TO THE REPAIR SITE. A REPLACEMENT DEVICE HAS BEEN ORDERED. NO REPLACEMENT PRODUCT IS REQUIRED, AND NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669997 ↗
• MalfunctionJan 2, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE DISTRIBUTION CENTER, IT WAS OBSERVED THAT THE SOCKET WRENCH FOR VEPTR NUT WAS OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424505 ↗
• MalfunctionDec 21, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, THE TORQUE WRENCH IN QUESTION WAS FOUND TO BE OUT OF SPEC. THE PRODUCT WAS TESTED USING A CALIBRATED TORQUE METER, THE MEASURED TORQUE VALUE WAS HIGHER THAN THE DRAWING SPECIFICATIONS. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372873 ↗
• MalfunctionDec 20, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE SOCKET WRENCH FOR VEPTR NUT WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367387 ↗
• MalfunctionDec 20, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS NOTED THAT THE SOCKET WRENCH FOR VEPTR NUT WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367350 ↗
• MalfunctionJul 24, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE SOCKET WRENCH FOR VEPTR NUT WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379496 ↗
• MalfunctionJun 7, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON MAY 23, 2023, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE MOORESVILLE MD DC, IT WAS OBSERVED THAT THE SOCKET WRENCH FOR VEPTR NUT WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083224 ↗
• MalfunctionJan 4, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED ON AN UNKNOWN DATE DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT THE SOCKET WRENCH FOR VEPTR NUT HAD FAILED IN CALIBRATION. ISSUE FOUND DURING TESTING AT SERVICE & REPAIRS/ MONUMENT. NO ADDITIONAL INFORMATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095367 ↗
• MalfunctionJan 4, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. ISSUE FOUND DURING TESTING AT SERVICE AND REPAIR. NO ADDITIONAL INFORMATION. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095009 ↗
• MalfunctionOct 18, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION, THE REPAIR TECHNICIAN FOUND THAT THE SOCKET WRENCH FOR VEPTR NUT FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629054 ↗
• MalfunctionOct 6, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION, THE REPAIR TECHNICIAN FOUND THAT THE TORQUE TEST FAILED LOW. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550223 ↗
• MalfunctionOct 5, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE REPAIR TECHNICIANS FOUND THAT THE TORQUE FAILED TEST HIGH. NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544457 ↗
• MalfunctionSep 28, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION, THE REPAIR TECHNICIAN FOUND THAT THE SOCKET WRENCH FOR VEPTR NUT FAILED CALIBRATION. THIS WAS DISCOVERED DURING TESTING AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499746 ↗
• MalfunctionSep 13, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION, THE REPAIR TECHNICIAN FOUND THAT ONE (1) SOCKET WRENCH FOR VEPTR NUT FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412925 ↗
• MalfunctionAug 19, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION THE REPAIR ON AN UNKNOWN DATE, THE SOCKET WRENCH FOR VEPTR NUT FAILED CALIBRATION. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259158 ↗
• MalfunctionAug 8, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR SOCKET WRENCH FOR VEPTR NUT HAD FAILED THE TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15184452 ↗
• MalfunctionJul 27, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR SOCKET WRENCH FOR VEPTR NUT HAD FAILED THE TORQUE TEST. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118121 ↗
• MalfunctionJul 8, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SOCKET WRENCH FOR VEPTR DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING AND HAS BEEN REMOVED FROM VEPTR-II INSTR+IMPL SET I/G-CASE LOANER SET. NO PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A SOCKET WRENCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14956757 ↗
• MalfunctionMar 25, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, A SOCKET WRENCH FOR VEPTR NUT HAD FAILED A TORQUE TEST DURING SERVICE AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOCKET WRENCH FOR VEPTR NUT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905240 ↗