NA 72201725Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010612816), received between Mar 27, 2018 and Oct 17, 2023 — classified as 8 malfunctions.

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

• MalfunctionOct 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUPINE TABLE BROKE WHILE PULLING TRACTION. THE PROCEDURE COULD NOT BE COMPLETED AND WAS RESCHEDULED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953868 ↗
• MalfunctionApr 14, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE SUPINE TABLE ATTACHMENT DID NOT LOCK AWAY PROPERLY DURING SET UP FOR A HIP SCOPE. THE SCREW WAS STRIPED SO THE ATTACHMENT COULD NOT BE SECURELY ATTACHED TO THE BED. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663425 ↗
• MalfunctionSep 17, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING ARTHROSCOPY, THE LEG HOLDER DETACHED FROM THE TABLE ATTACHMENT WHEN TRACTION WAS APPLIED TO THE OPERATIVE LEG, DESPITE ALL REQUIRED CHECKS BEING CARRIED OUT PRIOR TO SURGERY. THERE WAS A DELAY OF UNDER 30 MIN AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AND STANDARD SUPINE TECHNIQUE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10547153 ↗
• MalfunctionMar 10, 2020Positioning Failure; Material Separation; Positioning Failure; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE STRAP WHICH SECURES THE FOOT INTO THE ACTIVE HEEL TRACTION BOOT BROKE SINCE IT WAS ROUTINELY OVER TIGHTEN. SINCE THERE WAS NOT ANY BACK-UP DEVICE AVAILABLE, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; NEVERTHELESS, THE PROCEDURE WAS NOT DELAYED AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9814132 ↗
• MalfunctionMar 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE STRAP WHICH SECURES THE FOOT INTO THE ACTIVE HEEL TRACTION BOOT BROKE SINCE IT WAS ROUTINELY OVER TIGHTEN. SINCE THERE WAS NOT ANY BACK-UP DEVICE AVAILABLE, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; NEVERTHELESS, THE PROCEDURE WAS NOT DELAYED AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9808750 ↗
• MalfunctionAug 26, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE OPERATIVE LEG HAS COME OUT OF THE SUPINE TABLE ATTACHMENT MID PROCEDURE WHEN THE SURGEON WAS MOVING THE LEG BACK INTO EXTENSION DURING THE OSTEOPLASTY. A KNOT WAS NOT TIED UP WHEN THE PROCEDURE WAS TAKING PLACE. A LOSS OF TRACTION WAS REPORTED DURING USE. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8930138 ↗
• MalfunctionMar 11, 2019Break

  IT WAS REPORTED THAT THE PLATE BROKE OFF. THERE WAS PATIENT INVOLVED, THE SAME DEVICE WAS ABLE TO BE USED AND THE PROCEDURE WAS DELAYED FOR MORE THAN 60 MINUTES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8410461 ↗
• MalfunctionMar 27, 2018Detachment Of Device Component

  IT WAS REPORTED DURING SET-UP FOR A HIP POSITIONING SYSTEM, THE UNIVERSAL HIP DISTRACTOR WERE ATTACHED TO THE TABLE EXTENSION, THE OPERATOR FULLY INSERTED INTO THE SOCKET AND TIGHTENED THE HOLDER KNOB. AFTER SETTING-UP THEM, TO APPLY TENSION TO THE WELL LEG, WHEN THE LEG HOLDER WAS PULLED, THE HIP DISTRACTOR CAME OFF FROM THE TABLE EXTENSION AND THE PATIENT LEGS FALL OFF. THIS HAPPENED DURING PREPARATION OF THE PROCEDURE, NO SURGICAL INSTRUMENTS WERE INSIDE THE PATIENT. THERE WAS NO REPORT OF PROCEDURAL DELAY. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Fall

  MAUDE report 7375414 ↗