NA 014407Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010095329), received between Oct 29, 2020 and Dec 31, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (4 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.

• MalfunctionDec 31, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING THE SURGERY IT WAS FOUND A FOREIGN MATTER INSIDE THE STERILE ANKLE DISTRACTOR FOOT STRAPS PACKAGE. NO PATIENT INJURIES OR DELAY REPORTED. UNKNOWN IF THERE WAS A BACK-UP DEVICE TO COMPLETE THE SURGERY. 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 11100324 ↗
• MalfunctionDec 31, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING THE SURGERY IT WAS FOUND A FOREIGN MATTER INSIDE THE STERILE ANKLE DISTRACTOR FOOT STRAPS PACKAGE. NO PATIENT INJURIES OR DELAY REPORTED. UNKNOWN IF THERE WAS A BACK-UP DEVICE TO COMPLETE THE SURGERY. 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 11100320 ↗
• MalfunctionDec 31, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING THE SURGERY IT WAS FOUND A FOREIGN MATTER INSIDE THE STERILE ANKLE DISTRACTOR FOOT STRAPS PACKAGE. NO PATIENT INJURIES OR DELAY REPORTED. UNKNOWN IF THERE WAS A BACK-UP DEVICE TO COMPLETE THE SURGERY. 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 11100318 ↗
• MalfunctionDec 31, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING THE SURGERY IT WAS FOUND A FOREIGN MATTER INSIDE THE STERILE ANKLE DISTRACTOR FOOT STRAPS PACKAGE. NO PATIENT INJURIES OR DELAY REPORTED. UNKNOWN IF THERE WAS A BACK-UP DEVICE TO COMPLETE THE SURGERY. 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 11100316 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PROCEDURE WITH FOOT STRAP DISTRACTORS, THE PATIENT DEVELOPED SKIN INFLAMMATION. PATIENT'S OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Skin Inflammation

  MAUDE report 10759818 ↗