FOOTPRINTRecalls & reported problems across all models

We found 5 models of FOOTPRINT by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 963 adverse event reports in the FDA's MAUDE database, received between May 25, 2017 and Jun 29, 2026 — classified as 332 injuries, 631 malfunctions.

The most frequently reported specific device problem is “Break” (617 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FOOTPRINT problems

FOOTPRINT models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FOOTPRINT 72202901

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  721 reports
• FOOTPRINT 72202902

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  215 reports
• FOOTPRINT 72203783

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  19 reports
• FOOTPRINT 72205687

  Fastener, fixation, nondegradable, soft tissue
  5 reports
• FOOTPRINT 72203776

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  3 reports

Recent FOOTPRINT adverse event reports

The 15 most recent reports across all models, 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 28, 2026Failure to Advance

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE FOOTPRINT ANCHOR FAILED TO TIGHTEN THE COIL. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647262 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT DURING A MEDIAL COLLATERAL LIGAMENT REPAIR, WHEN THE SURGEON BEGAN PLACING THE FOOTPRINT ANCHOR, IT WAS OBSERVED THAT THE ANCHOR HAD BROKEN. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED, AND IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25616945 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT, DURING A ROOT REPAIR, THE FOOTPRINT ANCHOR BROKE OFF DURING TIBIAL SITE INSERTION. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25616419 ↗
• 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 19, 2026Break

  IT WAS REPORTED THAT, DURING AN ATFL PROCEDURE, A FOOTPRINT ULTRA ANCHOR BROKE DURING INSERTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217576 ↗
• 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 ↗

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