NA 511.771Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982237774), received between May 11, 2021 and Sep 7, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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.

• MalfunctionSep 7, 2021Detachment of Device or Device Component; Complete Loss of Power; Detachment of Device or Device Component; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE FAILED VISUAL INSPECTION. IT WAS DETERMINED THAT THE DEVICE WAS RECEIVED FALLEN APART AND THE TOOL COUPLING AND THE MAIN BODY HAD UNSCREWED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION AND CHECK THE TORQUE. THE DEVICE WAS REASSEMBLED FOR ASSESSMENT OF THE TORQUE UNIT AND ALL TORQUE MEASUREMENTS PASSED. IT WAS NOTED IN THE SERVICE ORDER THAT HALFWAY THROUGH AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TORQUE LIMITER WAS SPINNING AND NO LONGER WORKED. IT WAS REPORTED THAT THERE WAS A MINIMAL TIME DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY WITHOUT ANY ISSUES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434530 ↗
• MalfunctionAug 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ATTACHMENT DEVICE HAD COME APART. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT, IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366994 ↗
• InjuryJul 16, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TORQUE LIMITING ATTACHMENT DEVICE WAS LOCKED MAKING IT IMPOSSIBLE TO LOCK AND TIGHTEN SCREWS WITH IT. IT WAS FURTHER REPORTED THAT THE TIPS OF THE SCREWS TIGHTENING WRENCHES, ALSO DID NOT FIT DUE TO THE DEVICE BEING LOCKED. ACCORDING TO THE REPORTER, THIS MADE IT IMPOSSIBLE TO PROPERLY INSERT THE LOCKING SCREWS. IT WAS NOTED THAT THE DRILL BITS WERE BLUNT AND CROOKED WHICH LEAD TO LONGER SURGERY TIME. IT WAS REPORTED THAT THERE WAS AN INCREASE IN SURGICAL TIME OF ONE HOUR AND THERE WAS LIGAMENT INJURY TO THE PATIENT. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12184901 ↗
• MalfunctionJul 14, 2021Premature Separation; Premature Separation

  IT WAS REPORTED FROM THE (B)(6) THAT THE TORQUE LIMITING ATTACHMENT DEVICE UNSCREWED WHEN USING ANTI CLOCKWISE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170174 ↗
• MalfunctionMay 11, 2021Device Slipped; Mechanical Jam; Device Slipped; Mechanical Jam

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE TORQUE ATTACHMENT DEVICE WOULD NOT WORK AT ALL DUE TO THE INTERNAL PARTS OF THE DEVICE SHIFTING BACK. THIS ALSO MADE IT IMPOSSIBLE TO INSERT THE CUTTING TOOL DEVICE. DURING A VISUAL INSPECTION, IT WAS OBSERVED THAT THE THREAD OF THE HOUSING CAME LOSE. IT WAS NOTED IN THE SERVICE ORDER THAT THE THREAD OF THE HOUSING OF THE TORQUE ATTACHMENT DEVICE BECAME LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805340 ↗