FOOTPRINT 72202902Recalls & reported problems

Summary

The FDA's MAUDE database contains 215 adverse event reports that list this exact device (DI 03596010650535), received between Sep 21, 2017 and Jun 28, 2026 — classified as 59 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Break” (125 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 215 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 11, 2026Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE FOOTPRINT ULTRA PK ANCHOR FRACTURED INSIDE THE PATIENT. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING GRASPERS AND SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP INSERTED INTO THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145271 ↗
• MalfunctionApr 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE 5.5MM FOOTPRINT ANCHOR WAS PASSED, THE 2 STRANDS OF ULTRABRAID WERE THREADED AND IMPACTED HALFWAY TO REMOVE THE STRAND THAT HOLDS THE FOOTPRINT TO THE HANDLE OF THE IMPLANT. THEN, THE IMPACT CONTINUED WITHOUT RESISTANCE UNTIL THE STOP AND THE INTERNAL SCREW WAS PREPARED TO LOWER TO HOLD THE STRANDS THAT WERE INSIDE THE FOOTPRINT. THE HANDLE WAS REMOVED AND WHEN THE DOCTOR PULLED THE STRANDS, THE STRANDS CAME OUT OF THE ANCHOR, LEAVING THE FOOTPRINT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 25052384 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, THE ANCHOR BROKE WHEN IT WAS SCREWED IN AFTER OPENING A HOLE WITH THE GOLD CONE. THE ANCHOR WAS REMOVED. 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 25029763 ↗
• MalfunctionApr 15, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER THE INTERNAL FIXATION WAS COMPLETED, PREPARATIONS WERE MADE FOR THE SUTURE BRIDGE SURGERY. A 3.8 CONICAL BONE AWL WAS USED TO CREATE A PATH, AND THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, THEN, WHEN A FOOTPRINT ULTRA SUTURE ANCHOR WAS BEING IMPLANTED, IT BROKE. THE BROKEN PIECES WERE REMOVED USING GRASPERS AND SUCTION. 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 NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887854 ↗
• MalfunctionApr 9, 2026Fracture

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, ONE (1) FOOTPRINT ULTRA ANCHOR FRACTURED AT THE TIME OF PLACEMENT. THE FRACTURED PIECES WERE REMOVED USING A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830143 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE FOOTPRINT ANCHOR BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT, HOWEVER IT IS UNKNOWN HOW. 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 24701975 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, A FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5 WAS FRACTURED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION AND ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617169 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE FOOTPRINT ULTRA PK ANCHOR BROKE DURING INSERTION AT THE TIBIAL SITE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383466 ↗
• MalfunctionJan 21, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, ONE FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5 DID NOT PRESS THE SUTURE. 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 24141728 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE FOOTPRINT ULTRA PK ANCHOR BROKE. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING GRASPERS AND SUCTION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP INSERTED INTO THE ORIGINAL BONE HOLE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090583 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, AFTER THE CONSTRUCTION WITH THE MATCHING TOOLS, ONE (1) FOOTPRINT SUTURE ANCHOR BROKE DURING IMPLANTATION. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO VOID LEFT. THE PATIENT'S STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927752 ↗
• MalfunctionDec 30, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, THE FOOTPRINT ULTRA PK LATERAL ANCHOR CAME OUT AND THE ANCHOR HOLDING THREAD ALSO BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923435 ↗
• MalfunctionDec 29, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FOOTPRINT ULTRA ANCHOR COULDN'T BE HAMMERED IN AND THEN CRACKED. 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 23917003 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, NORMAL TO OPEN THE ROAD, A FOOTPRINT ULTRA ANCHOR BROKE AS IT WAS IMPLANTED. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP, YET IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905865 ↗
• MalfunctionDec 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A PCL PROCEDURE, THE FOOTPRINT ULTRA PK ANCHOR BROKE DURING IMPLANTATION. ALL THE PIECES WERE REMOVED FROM INSIDE THE PATIENT USING SUCTION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP INSERTED INTO THE ORIGINAL BONE HOLE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799575 ↗
• MalfunctionDec 10, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE INNER PACKAGE OF THE FOOTPRINT ULTRA PK ANCHOR HAD A TEAR. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767207 ↗
• MalfunctionDec 9, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE AN ARTHROSCOPY, IT WAS NOTICED THAT THE PACKAGING OF THE FOOTPRINT ULTRA PEEK SUTURE ANCHOR APPEARED VISUALLY DAMAGED NEAR THE OPENING. AFTER OPENING IT, THE SURGEON EXPRESSED CONCERN ABOUT THE POSSIBLE COMPROMISED STERILITY. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757591 ↗
• MalfunctionDec 3, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, ONE (1) FOOTPRINT ULTRA SUTURE ANCHOR BROKE WHILE 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 23703747 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, ONE (1) FOOTPRINT ULTRA SUTURE ANCHOR WAS INSERTED INTO THE BONE HOLE, AND DURING THE IMPLANTATION PROCESS, THE 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 23700894 ↗
• MalfunctionNov 15, 2025Break; Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE FOOTPRINT ULTRA PK ANCHOR BROKE HALFWAY THROUGH THE HAMMERING PROCESS. THE ANCHOR WAS REPLACED AND RE-IMPLANTED. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK UP, IT IS UNKNOWN IF ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23564243 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY, THE FOOTPRINT ULTRA PEEK SUTURE ANCHOR TIP BROKE UPON IMPACT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532584 ↗