FOOTPRINT 72202901Recalls & reported problems

Summary

The FDA's MAUDE database contains 721 adverse event reports that list this exact device (DI 03596010650528), received between May 25, 2017 and Jun 29, 2026 — classified as 264 injuries, 457 malfunctions.

The most frequently reported specific device problem is “Break” (472 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 25 most recent of 721 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, ONE (1) FOOTPRINT ULTRA PK SUTURE ANCHOR WAS BROKEN DURING THE IMPLANTATION. THE PROCEDURE WAS RESUMED WITH AN EQUIVALENT S+N BACK UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS REPORTED. NO SURGICAL REPORT IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648634 ↗
• MalfunctionJun 21, 2026Break

  IT WAS REPORTED THAT, DURING SHOULDER PROCEDURE, THE FOOTPRINT ANCHOR WAS FRACTURED. THE BROKEN DEVICE WAS REMOVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572646 ↗
• MalfunctionJun 14, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ALCHILLES TENDON REPAIR SURGERY, THE FOOTPRINT ANCHOR WAS FRACTURED. ALL THE PIECES WERE REMOVED WITH GRASPERS. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED HOLE, NO VOIDS WERE LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A 3,8MM BONE CONE AND THE SITE WAS CLEARED OF ALL DEBRIS. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25496846 ↗
• MalfunctionJun 10, 2026Failure to Cycle

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THERE WAS AN ABNORMAL NOISE FROM THE SCREW KNOB OF ONE (1) FOOTPRINT ULTRA SUTURE ANCHOR, THEREFORE, THE SUTURE COULD NOT BE LOCKED. THE BONE QUALITY OF THE PATIENT WAS FINE AND THERE WAS NO VOID LEFT IN THE PATIENT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR, 3.8MM BONE CONE WAS USED TO PREPARE THE INSERTION SITE. THE PROCEDURE WAS RESUMED, WITH NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP PRODUCT, WHICH WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466106 ↗
• MalfunctionJun 3, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HEAD OF THE FOOTPRINT ULTRA ANCHOR BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT BY SUCTION AND TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386209 ↗
• MalfunctionJun 2, 2026Fracture; Premature Separation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER PREPARING THE INSERTION SITE WITH A 3.8 MM BONE CONE AND CLEARING IT OF ALL DEBRIS, A FOOTPRINT ULTRA ANCHOR'S BODY BECAME LOOSE AND DETACHED FROM THE INSERTER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25369079 ↗
• MalfunctionJun 1, 2026Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT, DURING A SURGERY, WHEN THE FOOTPRINT ANCHOR WAS OUTSIDE THE PATIENT, IT WAS NOTICED THAT AN ABNORMAL NOISE FROM THE FOOTPRINT ANCHOR¿S INNER PLUG, AND THE SUTURES COULD NOT BE SECURED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353052 ↗
• MalfunctionMay 31, 2026Material Integrity Problem

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF TEAR SURGERY, WHILE DEPLOYING ONE (1) FOOTPRINT ULTRA SUTURE ANCHOR AT THE LATERAL ROW, THE IMPLANT PEEK MATERIAL WAS DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342935 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, IMPLANTATION WAS INITIATED USING A 3.8 MM GOLD PUNCH; BOTH SUTURES WERE PASSED THROUGH ONE (1) FOOTPRINT ULTRA ANCHOR 4.5 MM AND POSITIONED IN THE DRILLED HOLE, HOWEVER, AFTER ONLY A FEW IMPACTS (APPROXIMATELY THREE), THE IMPLANT BROKE. ALL BROKEN PIECES WERE REMOVED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. DUE TO THE ISSUE, THE BONE HOLE WAS BIGGER THAN INTENDED, THEREFORE, A FOOTPRINT ULTRA ANCHOR 5.5 MM BACK-UP WAS USED TO COMPLETE THE PROCEDURE. NO VOID LEFT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281113 ↗
• MalfunctionMay 17, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) FOOTPRINT ANCHOR BROKE. THE PROCEDURE WAS PERFORMED 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 25196718 ↗
• MalfunctionMay 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A FOOTPRINT ULTRA SUTURE ANCHOR 4.5 WAS USED, AND ABNORMAL NOISE OCCURRED IN THE ANCHOR¿S INTERNAL CORE, RESULTING IN FAILURE TO SECURE THE SUTURE, IT COULD NOT BE FULLY LOCKED. THE ANCHOR WAS NOT REMOVED FROM THE BODY DUE TO THIS ISSUE. SINCE THE ANCHOR HAD AN INVERTED BARBED STRUCTURE, THE SURGEON REPLACED IT WITH A NEW ANCHOR FROM THE STOCK SUPPLY AFTER CHECKING THAT THERE WAS A PROBLEM WITH THE PRODUCT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, NO VOIDS WERE LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A 3,8 MM BONE CONE AND THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT STATUS WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25164969 ↗
• MalfunctionMay 11, 2026Fracture

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) FOOTPRINT ULTRA ANCHOR WAS FRACTURED WHEN IT WAS BEING IMPLANTED. THE PROCEDURE WAS PERFORMED 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 25142332 ↗
• MalfunctionMay 4, 2026Break; Premature Activation

  IT WAS REPORTED THAT, DURING A LONG HEAD OF THE BICEPS TENDON TENODESIS, THE SURGEON TESTED THE INTEGRITY OF THE FOOTPRINT ULTRA PEEK SUTURE ANCHOR AND FOUND THAT IT FAILED, INDICATING IT HAD PULLED OUT OR OTHERWISE BECOME UNUSABLE. THE IMPLANT WAS FIRED WHEN TESTING, AND DID NOT MAKE CONTACT WITH THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT SN BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068050 ↗
• MalfunctionMay 1, 2026Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, THE FOOTPRINT ANCHOR WAS FRACTURED AS IT WAS HAMMERED IN. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058175 ↗
• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, ONE (1) FOOTPRINT ULTRA SUTURE ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919858 ↗
• MalfunctionApr 18, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, ONE (1) FOOTPRINT ULTRA SUTURE ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919857 ↗
• MalfunctionApr 17, 2026Failure to Advance; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE FOOTPRINT ANCHOR MADE AN ABNORMAL NOISE AND COULD NOT LOCK THE INNER BOLT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911486 ↗
• MalfunctionApr 15, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS PREPARED WITH A 3.8 MM BONE CONE AND CLEARED OF ALL DEBRIS, A FOOTPRINT ULTRA ANCHOR COULD NOT FIX THE SUTURE AS EXPECTED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887925 ↗
• MalfunctionApr 13, 2026Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE FOOTPRINT ANCHOR WAS FRACTURED WHEN IMPLANTING. THE BROKEN PIECES WERE REMOVED USING TWEEZERS AND CLAMPS. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE; THERE WAS NO VOID LEFT IN THE PATIENT. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859456 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT DURING AN ATFL REPAIR, ONE (1) FOOTPRINT ULTRA ANCHOR BROKE HALFWAY WHEN BEING MALLETED IN. THE HALF IS STILL EMBEDDED INSIDE THE BONE. THE BROKEN HALF PIECE WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT IN AN ADDITIONAL BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 24789717 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING SURGERY, ONE (1) FOOTPRINT ULTRA SUTURE ANCHOR BROKE DURING IMPLANTATION. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714190 ↗
• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY AND ROTATOR CUFF PROCEDURE, THE PATIENT'S BONE WAS VERY HARD AND THE FOOTPRINT FRACTURED DURING ITS INSERTION. THE DEVICE WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A CHANGE IN THE SURGICAL TECHNIQUE SUCH AS DOUBLE ROW INCOMPLETE, A VOID WAS LEFT IN PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654857 ↗
• MalfunctionMar 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE FOOTPRINT ULTRA ANCHOR DETACHED DURING SUTURE THREADING. THE DEVICE WAS REMOVED WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP ON THE ORIGINALLY DRILLED BONE HOLE MADE WITH ANCHOR MATCHING INSTRUMENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545034 ↗
• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, ONE FOOTPRINT ULTRA PK SUTURE ANCHOR BODY FRACTURED DURING IMPACTION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, WITH A SN EQUIVALENT DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541174 ↗
• MalfunctionMar 5, 2026Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE FOOTPRINT ULTRA ANCHOR FELL OFF. THE PROCEDURE WAS COMPLETED WITH A SN EQUIVALENT DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524353 ↗