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
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 ↗
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- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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