Active Heel Traction Boot 72203270Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885554024821), received between Dec 13, 2017 and Nov 3, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Unstable” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, DURING THE EARLY PORTION OF THE PROCEDURE, THE TRACTION OF THE UNIVERSAL HIP DISTRACTOR WAS LOST. ATTEMPTS TO RE-TRACTION THE JOINT FAILED. UPON FURTHER INSPECTION, IT WAS NOTED THE CARRIAGE KNOB OF THE OPERATIVE SIDE MAST WAS BROKEN. SPECIFICALLY, A PIN SHEARED THAT ATTACHED THE KNOB TO THE BOLT THAT TIGHTENS THE DISTRACTOR BOOT ASSEMBLY TO THE MAST. THE PROCEDURE WAS COMPLETED WITH A SURGICAL GREATER THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. THERE WAS PROLONGED TIME UNDER ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459989 ↗
• InjuryNov 29, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY, THE BOLT OF THE UNKN ILIZAROV EXFIX INSTR DEVICE THAT CLAMPS THE TRACTION SLIDER IN POSITION, CAME APART AND WAS NOT ABLE TO TIGHTEN THE CLAMP SUFFICIENTLY. THE SURGEON USED A VICE GRIP TO RESOLVE THIS PROBLEM. ONCE THAT WAS FIXED, THE ORANGE STRAPS THAT HOLD THE FOOT INTO THE SUPPORT WERE SLIDING THROUGH THE CLASPS ALLOWING THE HEAL TO BE RAISED OUT OF THE SUPPORT. THEREFORE, THE PROCEDURE COULD NOT BE PERFORMED. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE PROCEDURE HAS BEEN POSTPONED. 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 15875767 ↗
• MalfunctionJul 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE HIP DISTRACTION PROCESS, THE METAL INNER SHEATH OF THE FINE TRACTION BROKE OFF INTO THE THREADS. IT WAS UNABLE TO PROVIDE TRACTION USING THE FINE TRACTION BLACK HANDLE. THERE WAS A BACKUP DEVICE AVAILABLE. A DELAY OF MORE THAN 30 MIN WAS REPORTED. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155901 ↗
• MalfunctionMay 17, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE HIP DISTRACTOR DID NOT LOCK INTO THE PLACE, IT STILL MOVES. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831531 ↗
• MalfunctionMay 6, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE BALL AND SOCKET JOINT ON THE HIP DISTRACTOR WAS NOT HOLDING THE FOOT IN PLACE AND THEREFORE THE FOOT CONTINUOUSLY SLIPS OUT OF PLACE. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11782997 ↗
• MalfunctionApr 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING SURGERY, THE TRACTION IN THE "AHB UNIVERSAL HIP DISTRACTOR" WAS NOT WORKING CORRECTLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE, BUT IT WAS HARDER THAN USUAL. NO PATIENT INJURIES 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 11628623 ↗
• InjuryMar 30, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING A HIP SCOPE, THE UNIVERSAL HIP DISTRACTOR WAS UNABLE TO LOCK, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE, THE LEG WAS LOCKED MANUALLY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11587951 ↗
• MalfunctionFeb 16, 2021Unstable; Material Twisted/Bent; Unstable; Material Twisted/Bent

  IT WAS REPORTED THAT, THE HANDLE OF THE "AHTB UNIVERSAL HIP DISTRACTOR" WAS BENT, SO IT DID NOT STAY IN ONE POSITION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11333776 ↗
• MalfunctionJan 25, 2021Unstable; Unstable

  IT WAS REPORTED THAT, THE BALL JOINT IN THE "UNIVERSAL HIP DISTRACTOR" COULD NOT HOLD THE BOOT/LEG IN POSITION. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. 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 11221346 ↗
• MalfunctionJan 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE THREADED ROD OF THE HIP DISTRACTOR WAS STRIPPED, WHICH CAUSED THE DEVICE TO NOT PULL ANY TRACTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11165146 ↗
• MalfunctionAug 26, 2020Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THE UNIVERSAL HIP DISTRACTOR'S ORANGE KNOB FOR GROSS TRACTION WILL NOT TIGHTEN/LOOSEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10455135 ↗
• MalfunctionAug 6, 2020Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING ARTHROSCOPY SURGERY, WHILST DISTRACTING THE PATIENT'S LEG THE THREAD ON THE SILVER PART OF THE DISTRACTOR SEEMED TO SNAP AND COME OFF ON THE OTHER LONG THREADED COLUMN. THE KIT WAS BEEN PROPERLY USE AND NOT EXCESSIVE STRAIN WAS APPLIED TO THE PRODUCT. THERE WAS A DELAY OF GREATER THAN 30 MIN AND THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. 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 10372411 ↗
• MalfunctionJul 7, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, THE "AHTB UNIVERSAL HIP DISTRACTOR" WAS LOCKED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10242718 ↗
• MalfunctionMar 4, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE HIP DISTRACTOR BALL JOINT CANNOT HOLD THE PATIENT POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. 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 9789808 ↗
• MalfunctionAug 26, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A HIP SURGERY THE NEW BOOT AND THE ARM DID NOT SLIDE SMOOTHLY TOGETHER. IT WAS VERY RIGID AND HARD TO GET TRACTION. A DELAY GRATER THAT 30 MINUTES WAS REPORTED AND NO PATIENT INJURIES WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8931420 ↗
• MalfunctionJan 28, 2019Device Slipped

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE WORN KNOB THAT HOLDS THE BOOT ON THE MAIN DISTRACTOR LEG WAS SLIPPING. THE PA HELD THE FOOT IN PLACE WHILE THE SURGEON COMPLETED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NEITHER SURGICAL DELAY NOR PATIENT INJURIES WERE STATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8281285 ↗
• MalfunctionJan 24, 2019Fitting Problem

  IT WAS REPORTED THAT DURING THE SURGERY THE BALL JOINT ON AHTB ATTACHMENT WOULD NOT LICK IN PLACE ADEQUATELY WHEN THE PATIENTS LEG WAS IN THE BOOT. THE SURGICAL ASSISTANT HAD TO HOLD THE LEG IN THE REQUIRED POSITION FOR THE SURGEON. NO BACK UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8275893 ↗
• MalfunctionJan 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THA THE HIP DISTRACTOR WAS PRESENTING TRACTION ISSUES WITH THE TIGHTENING KNOB. THE SURGEON SAW IT SLIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7227953 ↗
• MalfunctionDec 14, 2017Mechanical Problem; Connection Problem

  IT WAS REPORTED THAT THE BALL/SOCKET JOINT AT THE TABLE ATTACHMENTS END CANNOT HOLD THE LEG IN PLACE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7117468 ↗
• MalfunctionDec 13, 2017Unstable

  IT WAS REPORTED THAT THE BALL/SOCKET JOINT AT THE TABLE ATTACHMENTS END CANNOT HOLD THE LEG IN PLACE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7115428 ↗