FOOTPRINT 72203783Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885554029406), received between Jan 31, 2018 and Oct 15, 2025 — classified as 8 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (13 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, A 4MM FOOTPRINT DRILL WAS USED TO CREATE A BONE HOLE, UPON THE INSERTION, IT WAS NOTICED THAT THE DISTAL TIP OF THE FOOTPRINT ULTRA ANCHOR SNAPPED. THE DEVICE WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE SAME BONE HOLE AND NO MATERIAL WAS LEFT IN THE PATIENT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287061 ↗
• MalfunctionJan 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A GLUTEUS MEDIUS REPAIR PROCEDURE, THE FOOTPRINT ANCHOR WAS BENT UPON INSERTION, AND IT HAD TO BE REMOVED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, USED IN A NEW DRILLED BONE HOLE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21056151 ↗
• InjuryJul 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE SUTURE OF THE FOOTPRINT ANCHOR CAME LOOSE WHILE THE DEVICE WAS STILL ANCHORED IN PATIENT¿S TIBIA, AN ADDITIONAL BONE HOLE WAS REQUIRED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A 5 MINUTE SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19646834 ↗
• MalfunctionMay 29, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE FOOTPRINT ULTRA SUTURE ANCHOR BROKE WHEN ABOUT TO MALLET INTO THE BONE HOLE. THE TIP BROKE SUPERFICIALLY WITH IT TOUCHED THE ENTRY POINT OF THE HOLE, THUS, IT WAS EASILY REMOVED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE AND THE INSERTION SITE WAS SUCCESSFULLY CLEARED OF ALL DEBRIS. NO VOID LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19420148 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR, WHEN THE FOOTPRINT ULTRA SUTURE ANCHOR WITH THE SUTURES WAS BEING HAMMERED INTO THE TIBIA, THE TIP OF THE ANCHOR DISASSOCIATED. THE MAIN BODY OF THE ANCHOR WAS REMOVED WITH FORCEPS BUT THE TIP ABOUT 5MM REMAINED IN THE PATIENT WITH THE SUTURES THROUGH IT, AND THE SURGEON FELT IT WAS SAFER TO LEAVE IT IN AND JUST IMPACT ANOTHER ANCHOR BEHIND IT, A NEW ONE OF THE SAME TYPE WAS INSERTED WITHOUT ANY ISSUE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19315855 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A LEFT KNEE ARTHROSCOPIC SURGERY, THE FOOTPRINT ANCHOR BROKE AFTER SUTURES WERE PASSED THROUGH THE IMPLANT. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING ARTERY FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE USED IN THE ORIGINAL DRILLED BONE HOLE. THERE WAS A SURGICAL DELAY OF 5 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809304 ↗
• InjuryOct 11, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, 2 FOOTPRINT ANCHORS BROKE WHILE MALLETING THEM INTO A BONE TUNNEL PREPARED WITH 4.0MM DRILL. THE SURGEON GAVE UP ON PUTTING IN A SECONDARY FIXATION AS PLANNED. THE BROKEN PIECES WERE REMOVED WITH TWEEZER AND SUCTION, HOWEVER, THE TIP OF THE 2ND IMPLANT WAS EMBEDDED IN THE TUNNEL. THE DOCTOR DECIDED TO ABORT THE PROCEDURE. BONE QUALITY WAS HARD. PATIENT STATUS IS RECOVERING.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 17916649 ↗
• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN KNEE ACL, A FOOTPRINT ULTRA WAS INSERTED AND PUSHED INTO A 4MM BONE HOLE DRILLED INTO THE TIBIA; THE INSERTION SITE HAD BEEN PREPARED WITH A 4MM TRIGEN DRILL SHORT, THEN WHEN USING A MALLET TO SEAT THE IMPLANT, THE TIP OF THE IMPLANT SNAPPED. THE BROKEN TIP WAS REMOVED FROM THE TIBIA. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE THAT WAS AVAILABLE AND OPENED TO COMPLETE THE IMPLANTATION OF THE ANCHOR WITHOUT ANY OTHER ISSUES IN THE SAME BONE HOLE ORIGINALLY DRILLED; THEREFORE NO VOIDS WERE LEFT IN THE PATIENT.. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695033 ↗
• InjuryAug 24, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE FOOTPRINT ANCHOR BROKE UPON INSERTION TO THE TIBIA. ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287330 ↗
• InjuryMar 25, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND MENISCAL ROOT REPAIR, AS SURGEON WAS IMPACTING THE FOOTPRINT, SIDE WINGS STARTED BREAKING UP. THE BONE QUALITY WAS NORMAL, NOT TOO HARD. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THE BACK UP WAS USED IN THE SAME BONE HOLE AND ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH GILLIES FORCEPS AND SUCTION. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905952 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FOOTPRINT ANCHOR BROKE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF IT OCCURRED INSIDE OR OUTSIDE OF THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13395659 ↗
• InjuryOct 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MEDIAL INSTABILITY PROCEDURE OF ONE PATIENT WITH A FOOTPRINT ULR 5.5 PK SUT, SL, IT WAS NECESSARY TO GO UP TO LARGER SIZE 5.5 BECAUSE THE 4.5 WAS PULLED OUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651473 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, IT WAS NOTICED THAT THE FOOTPRINT ANCHOR WAS NOT PROPERLY LOADED INTO THE INSERTER WHEN CAME OUT OF THE BOX AND IT SMASHED AS SOON AS IT WAS INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048435 ↗
• InjuryMar 3, 2021Break; Break

  IT WAS REPORTED THAT DURING USE OF THE FOOTPRINT ULR 4.5 PK SUT SL-PLUS THE THREADS OF FOOTPRINT ANCHOR BROKE WHEN INSERTED INTO BONE. TIED SUTURES OVER ENDOBUTTON INSTEAD. THE CASE WAS COMPLETED WITH A BACKUP DEVICE WITHOUT FURTHER ISSUES, NO HARM TO THE PATIENT, AND NO OTHER COMPANIES PRODUCTS WERE USED. THERE WAS A DELAY LESSER THAN 30 MINUTES. 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 11405537 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, THE DR. HAD DIFFICULTY INSERTING TWO SUTURES INTO THE "4.5MM FOOTPRINT ANCHOR (PK SUT SL-PLUS)". AFTER INSERTING THE SUTURES AND IMPACTING THE ANCHOR, A PULL ON THE SUTURE TAILS CAUSED THE SUTURE TO BE DISLODGED FROM THE ANCHOR. DESPITE THIS, THE IMPLANT REMAINED LEFT SECURED IN THE PATIENT. ITS SUSPECTED THAT THE EYELET OF THE ANCHOR BROKE BUT IT CAN NOT BE CONFIRMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING ANOTHER "FOOTPRINT SL" TO ANCHOR THE SUTURE. NO FURTHER 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 11373978 ↗
• InjuryAug 5, 2020Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE GREEN RETENTION SUTURE OF THE FOOTPRINT DID NOT HOLD THE ANCHOR ON THE INSERTER, CAUSING THE ANCHOR TO FELL OFF STRAIGHT OUT OF THE PACKET INSIDE THE PATIENTS ANATOMY. IT WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. NO 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 Information

  MAUDE report 10369247 ↗
• MalfunctionJul 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FOOTPRINT SPLIT IN TWO UPON INSERTION. IT IS UNKNOWN IF A BACK UP DEVICE WAS AVAILABLE OR IF A DELAY WAS CAUSED DUE TO THE DEVICE MALFUNCTION, BUT NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8813455 ↗
• MalfunctionJul 19, 2018Break

  IT WAS REPORTED THAT THE ANCHOR BROKE UPON INSERTION. NO PATIENT INJURY WAS REPORTED. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7705079 ↗
• MalfunctionJan 31, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE HOLE AT THE END OF THE ANCHOR WAS NOT ALLOWING ANY SUTURES THROUGH. THE SURGEON TRIED SEVERAL TIMES AND ENDED UP OPENING A NEW ANCHOR WHICH WORKED PERFECTLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7232801 ↗