ULTRABUTTON 72290003Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00885556613825), received between Nov 30, 2017 and Jun 29, 2026 — classified as 48 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (40 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A SURGERY, THE ULTRABUTTON FAILED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK UP DEVICE (INTERFERENCE SCREW). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661978 ↗
• MalfunctionJun 13, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, ONE (1) ULTRABUTTON ADJUSTABLE FIXATION DEVICE ADJUSTED THE POSITION THAT MADE IT POSSIBLE TO RAISE OR ENGAGE THE FEMUR, THE PLATE WAS REMOVED WHEN IT WAS TIME TO ADJUST THE POSITION AND IT WAS SMASHED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25495830 ↗
• MalfunctionJun 1, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, THE ULTRABUTTON ANCHOR WAS FRACTURED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355688 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE SHORTENING SUTURES OF THE ULTRABUTTON SNAPPED BELOW THE BUTTON. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852107 ↗
• MalfunctionApr 1, 2026Fracture

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, THE ULTRABUTTON ADJUSTABLE LOOP SUTURE FRACTURE AND COULD NOT BE USED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT¿S CONDITION IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753377 ↗
• MalfunctionMar 30, 2026Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE FIRST AND SECOND SHORTENING LOOPS OF AN ULTRABUTTON DEVICE TORE. NO SHARP-EDGED INSTRUMENTS WERE USED DURING SHORTENING. THE TORN ULTRABUTTON COULD BE PULLED OUT OF THE THIGH MUSCLE BY THE TRACTION SUTURE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724190 ↗
• InjuryMar 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT ACL PROCEDURE, IT WAS NOTICED THAT ON THE DAY AFTER SURGERY, A FOLLOW-UP KNEE JOINT DR REVEALED THAT (1) ULTRABUTTON FIXATION DEVICE WAS LOOSE AND NOT TIGHTLY ATTACHED TO THE FEMORAL CORTEX. A SECOND SURGERY WAS PERFORMED ON FEBRUARY 6TH FOR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520196 ↗
• MalfunctionFeb 4, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE LOOP OF ONE (1) ULTRABUTTON GOT DAMAGED WHILE PULLING THE BUTTON IN THE FEMORAL TUNNEL. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP PRODUCT. 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 24259610 ↗
• MalfunctionOct 29, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT, DURING A POSTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, DURING THE PROCESS OF STRETCHING THE TENDON, THE COIL OF TWO (2) ULTRABUTTON TIGHTENED AND PREVENTED THE COMPLETION OF THE SUBSEQUENT OPERATION. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414211 ↗
• MalfunctionOct 8, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING THE TRUNAV TECHNIQUE, WHEN OPENING ONE (1) ULTRABUTTON IT WAS NOTICED THAT THE POUCH WAS TORN, AND THE DOUBLE PACKAGING WAS MISSING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23245813 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE ULTRABUTTON'S SUTURE BROKE WHEN THE GRAFT WAS RAISED AND REACHED THE FEMUR. THE GRAFT WAS CYCLED TO SEE IF IT WAS TIGHT AND THE GRAFT RETURNED. IT DID NOT MAKE A SUFFICIENT AND STRONG ADJUSTMENT TO PREVENT THE GRAFT FROM RETURNING. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878373 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SURGICAL PROCEDURE ON (B)(6) 2025, ON A PATIENT PRESENTING ACROMIOCLAVICULAR JOINT DISLOCATION, IN WHICH AN ULTRABUTTON FIXATION DEVICE WAS USED, THE WOUND HEALED WELL AND THE PATIENT WAS DISCHARGED. AFTER DISCHARGE, THE WOUND SHOWED REDNESS, SWELLING, AND ABNORMAL EXUDATION. THEREFORE, THE PATIENT WAS READMITTED ON (B)(6) 2025 AND UNDERWENT DEBRIDEMENT AND SUTURING SURGERY. THE WOUND HEALED WELL AFTER THE SURGERY WITHOUT ANY OBVIOUS COMPLICATIONS.

  Patient problems: Erythema; Fluid Discharge; Swelling/ Edema

  MAUDE report 22391732 ↗
• MalfunctionJun 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREAD OF THE ULTRABUTTON GOT CUT OFF WHILE REDUCING THE GRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303689 ↗
• MalfunctionJun 13, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE ULTRABUTTON ADJUSTABLE FIXATION DEVICE WAS CLOSED ONCE THE PLATE WAS POSITIONED ON THE LATERAL CORTEX OF THE FEMUR, IT DID NOT LOCK. THE SYSTEM WAS RETURNED AND DID NOT LOCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING AN INTERFERENCE SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22200210 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE SUTURE OF AN ULTRABUTTON ADJUSTABLE ANCHOR BROKE; SURGERY WAS COMPLETED USING A BACK-UP DEVICE INSTEAD, WITH A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199726 ↗
• MalfunctionJun 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SNITCHING SUTURE OF THE ULTRABUTTON ADJUSTABLE FIXATION DEVICE GOT TORN AND COULD CAME OUT WHILE PULLING THROUGH FEMERAL TUNNEL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AS THE ONLY COMPLICATION AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186279 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE REDUCTION SUTURE OF THE ULTRABUTTONS GOT BROKEN WHILE PULLING THE GRAFT INTO THE FEMORAL TUNNEL. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186206 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PULLING SUTURE OF THE ULTRABUTTON ADJUSTABLE FIXATION DEVICE BROKE WHILE PROVIDING TENSION AND AFTER FIXING IT ON THE FEMORAL SIDE, THE SURGEON COULDN'T PROVIDE THE FINAL TENSION. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE AND THERE WAS DELAY GREATER THAT 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122084 ↗
• MalfunctionApr 19, 2025Break; Break

  IT WAS REPORTED THAT DURING SUTURE PULLING IN AN ARTHROSCOPY, THE LOOP OF THE ULTRABUTTON BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A S+N BACK UP DEVICE INSERTED INTO THE ORIGINAL BONE HOLE. THE PATIENT'S CONDITION REMAINED STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870056 ↗
• InjuryFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE THREADS OF THE ULTRABUTTON BROKE WHEN THE GRAFT WAS BEING RAISED. ALL THE PIECES WERE REMOVED, A SMALL INCISION WAS MADE TO REMOVE THE BUTTON BETRAYING THE WHITE AND GREEN THREADS OF THE REMAINING BUTTON. WITH THE HELP OF A GUIDE, THE PLATE WAS LIFTED AND REMOVED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 21425811 ↗
• InjuryFeb 18, 2025Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A ACL ST2 ROUTE RECONSTRUCTION SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, AND X-RAYS IMMEDIATELY AFTER SURGERY SHOWED NO PROBLEMS WITH THE BUTTON POSITION OR FLOATING, THE PATIENT COMPLAINED OF PAIN AT THE BUTTON IMPLANTATION. IN (B)(6) 2024, THE INFECTION TEST WAS NEGATIVE. AN MRI AND X-RAY WERE TAKEN IN (B)(6) 2024, AND IT WAS CONFIRMED THAT THE BONE HOLE HAD EXPANDED AND THE BUTTON WAS FLOATING. ON (B)(6) 2025 A REVISION SURGERY WAS PERFORMED AND THE BUTTON HAD COME OUT FROM THE BONE HOLE. WHEN THE BUTTON WAS REMOVED FROM THE BODY, IT WAS FOUND THE GRAFT ATTACHED TO THE BUTTON SHRINKS TO ITS LIMIT, BUT THE SUTURE WAS NOT BROKEN. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21400096 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE DOCTOR REMOVED THE FIBULAR GRAFT, BUT IT CAME OUT VERY THIN. IT WOULD FIT SMOOTHLY IN SIZE 6, BUT IT WAS ALSO SHORT. WHEN INSERTING THE SCREW, THE GRAFT BROKE IN TWO AND WAS REMOVED WITH THE ULTRABUTTON THREADS. THE DOCTOR REMOVED THE ULTRABUTTON AND TRIED TO USE THE SAME GRAFT, BUT IT DID NOT WORK. HE REMOVED BOTH GRAFTS FROM THE FLEXORS TO COMPLETE THE SURGERY.THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021435 ↗
• MalfunctionOct 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PACKAGE OF THE ULTRABUTTON WAS NOT COMPLETELY SEALED AND WAS NOT STERILE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507799 ↗
• MalfunctionOct 20, 2024Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHILE THE THREAD WAS BEING REDUCED, THE ULTRABUTTON GOT BROKEN. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490339 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN ACL AND LEMAIRE PROCEDURE USING AN ULTRABUTTON FIXATION DEVICE, THE PATIENT PRESENTED A STAPHYLOCOCCUS CAPRAE INFECTION. THE PATIENT'S KNEE WAS RINSED OUT WITH ANTIBIOTIC SOLUTION AND THE IMPLANTS REMAINED IN THE PATIENT.

  Patient problems: Bacterial Infection

  MAUDE report 20297382 ↗