NA 03.615.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034715339), received between Sep 6, 2019 and Nov 6, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET WAS OBSERVED THAT 2.5NM TORQUE LIMITING NUT DRIVER WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 2.5 ¿ 2.9 NM. THE TORQUE TESTED HIGH ¿ 2.98 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. THIS REPORT IS FOR ONE (1) 2.5NM TORQUE LIMITING NUT DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075940 ↗
• MalfunctionOct 6, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING EVALUATION AND REPAIR, THE TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.5NM TORQUE LIMITING NUT DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15553951 ↗
• MalfunctionSep 19, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THIS DEVICE FAILED CALIBRATION. ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5NM TORQUE LIMITING NUT DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446473 ↗
• MalfunctionMar 30, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING TESTING AT SERVICE AND REPAIR ON (B)(6) 2021, THE TORQUE LIMITING NUT DRIVER FAILED IN CALIBRATION. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.5NM TORQUE LIMITING NUT DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589404 ↗
• MalfunctionApr 27, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING TESTING AT SERVICE AND REPAIR, A TORQUE LIMITING NUT DRIVER DID NOT MEET CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000250 ↗
• MalfunctionApr 24, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THAT THE TORQUE LIMITING NUT DRIVER FAILED IN CALIBRATION. THE CALIBRATION FAILED DURING TESTING AT SERVICE AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.5NM TORQUE LIMITING NUT DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9995882 ↗
• MalfunctionJan 28, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING TESTING AT SERVICE AND REPAIR, THE 2.5NM TORQUE LIMITER FOR LOCKING NUT FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.5NM TORQUE LIMITING NUT DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9639221 ↗
• MalfunctionSep 13, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AUGUST 16, 2019, DURING TESTING AT SERVICE AND REPAIR, A TORQUE LIMITING NUT DRIVER FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9041627 ↗
• MalfunctionSep 6, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED ON JULY 11, 2019, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQUE LIMITING NUT DRIVER FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 8969930 ↗