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FOOTPRINT 72205687Recalls & reported problems

Smith & Nephew, Inc. · FOOTPRINT MINI PK 3.5MM · Class 2 · Implant

All models of FOOTPRINT (5)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556890769), received between Mar 25, 2025 and May 11, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break5

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • Perforation1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 11, 2026Break

    IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE FOOTPRINT MINI PK 3.5MM BROKE ON INSERTION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25145626 ↗
  • MalfunctionNov 3, 2025Break; Break

    IT WAS REPORTED THAT, DURING A PROCEDURE, A FOOTPRINT MINI ANCHOR BROKE BEFORE INSERTING INTO THE PRE-DRILLED HOLE. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23459683 ↗
  • MalfunctionAug 14, 2025Break; Break

    IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE FOOTPRINT ANCHOR BROKE WHILE TAPPING INTO THE BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22804596 ↗
  • MalfunctionApr 24, 2025Break; Break

    IT WAS REPORTED THAT, THE FOOTPRINT MINI PK 3.5MM BROKE OFF THE INSERTER WHILE IT WAS BEING MALLETED INTO THE DRILLED BONE HOLE IN THE TIBIA. THE ANCHOR CONTAINED 2 LIMBS OF ARTHREX FIBRETAPE AS PART OF AN ACL INTERNAL BRACE. A 3.5MM DRILL WAS USED TO PREP THE INSERTION SITE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED WITH ANOTHER 3.5MM FOOTPRINT MINI, USED IN THE SAME DRILLED BONE HOLE THAT WAS SUBSEQUENTLY DRILLED LARGER, A 4.5MM DRILL WAS USED. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21904021 ↗
  • MalfunctionMar 25, 2025Break; Break

    IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION WITH AN INTERNAL BRACE; AFTER PREPARING THE BONE HOLE WITH A 3.7 MM DRILL, THE FOOTPRINT MINI ANCHOR BROKE UPON INSERTION WHEN TAPPED INTO THE TIBIAL BONE. THE SURGERY WAS COMPLETED BY PLACING A BACK-UP DEVICE INTO THE ORIGINAL DRILLED BONE HOLE, WHICH WAS ENLARGED WITH A 4MM DRILL BIT. THE BROKEN PIECES WERE REMOVED USING GILLIES FORCEPS. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 21694107 ↗

Other Fastener, fixation, nondegradable, soft tissue devices

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Sources and updates

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