MULTIFIX 72290001Recalls & reported problems

Summary

The FDA's MAUDE database contains 217 adverse event reports that list this exact device (DI 00885556614204), received between Dec 8, 2017 and Jun 29, 2026 — classified as 98 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Break” (137 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 217 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE MULTIFIX ANCHOR FELL OFF AND PART OF IT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25648716 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE INSERTING THE MULTIFIX ANCHOR TIP GOT CUT. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING A SIMILAR S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356510 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT, DURING AN RC PROCEDURE, A MULTIFIX S ULTRA ANCHOR WAS BROKEN DURING INSERTION. 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 25356421 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT, DURING AN RC PROCEDURE, A MULTIFIX S-ULTRA ANCHOR WAS BROKEN DURING INSERTION. 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 25311093 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE TIP OF ONE (1) MULTIFIX ULTRA ANCHOR BROKE WHILE INSERTION IN LATERAL ROW REPAIR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, 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 25211610 ↗
• MalfunctionMay 7, 2026Material Deformation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF TEAR SURGERY WHILE DEPLOYING THE MULTIFIX ANCHOR AT THE LATERAL ROW, THE IMPLANT GOT DAMAGED. THE PROCEDURE WAS RESUMED, WITH A NON- SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113782 ↗
• MalfunctionFeb 26, 2026Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE MULTIFIX S-ULTRA 5.5 MM ANCHOR CRACKED WHEN IT WAS HAMMERED IN. THE PROCEDURE WAS RESUMED USING A RUIJIAN BACKUP PRODUCT 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 24465573 ↗
• MalfunctionFeb 24, 2026Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A MULTIFIX S-ULTRA KNOTLESS ANCHOR CAME OUT, IT WAS NOT FIXED IN THE BONE, AND IT WAS BROKEN. 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 24434260 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT, DURING SURGERY, WHEN HAMMERING IN ONE (1) MULTIFIX KNOTLESS ANCHOR IT CRACKED/BROKE. THE PROCEDURE WAS RESUMED, USING AN UNSPECIFIED COMPETITOR DEVICE, WITH A NON-SIGNIFICANT DELAY. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433147 ↗
• MalfunctionFeb 21, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR BROKE, THE TIP OF THE ANCHOR WAS CRACKED, AND IT WAS UNABLE TO SIT PROPERLY IN THE PREPARED SITE. 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 24410411 ↗
• InjuryFeb 20, 2026Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER A RIGHT ROTATOR CUFF SURGERY ON (B)(6) 2024 IN WHICH A MULTIFIX S ULTRA WAS IMPLANTED, THE PATIENT EXPERIENCED POST-OPERATIVE PERSISTENT SEVERE PAIN THAT CONDITIONED FUNCTIONAL ACTIVITIES, REQUIRING OPIOID ANALGESIA AND PROLONGED MAINTENANCE OF TAPENTADOL WITH A PROGRESSIVE INCREASE IN DOSAGE. PHYSIOTHERAPY TREATMENT IMPROVED JOINT MOBILITY, WITHOUT RESOLUTION OF THE PAIN. SUBSEQUENT IMAGING SHOWED SUBACROMIAL BURSITIS. ON (B)(6) 2024, AN MRI SCAN REVEALED THAT THE MULTIFIX ANCHOR WAS FRACTURED INTO TWO FRAGMENTS AND DISPLACED FROM ITS ORIGINAL POSITION, WHICH WAS CONFIRMED ON (B)(6) 2024 BY AN ULTRASOUND SCAN. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 TO ARTHROSCOPICALLY EXTRACT THE SUTURE ANCHOR FRAGMENT. DURING THE POST-OPERATIVE PERIOD, THE PATIENT SHOWED A SIGNIFICANT PAIN RELIEF AND RESUMED PHYSIOTHERAPY SESSIONS AFTER MEDICAL AUTHORIZATION. IN (B)(6) 2025, THE PAIN RETURNED WITH FUNCTIONAL WORSENING. IN (B)(6) 2025, AN MRI CONFIRMED THE PERSISTENCE OF BURSITIS; TREATMENT WITH PLATELET RICH PLASMA (PRP) WAS INDICATED AND CARRIED OUT ON (B)(6) 2025. A BILATERAL MRI WAS PERFORMED IN DECEMBER 2025 AND SHOWED A REDUCTION, BUT PERSISTENCE,

  Patient problems: Bursitis; Pain

  MAUDE report 24404756 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR PROCEDURE, IT WAS NOTICED THAT THE MULTIFIX 5.5MM KNOTLESS ANCHOR GOT BROKEN WHILE TAPPING IT. THE PIECES WERE REMOVED FROM BONE WITH HELP OF GRASPER. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON AN ADDITIONAL BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS GOOD AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24310910 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, A MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR WAS RUPTURED ON DENSE BONE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229031 ↗
• MalfunctionJan 26, 2026Separation Failure

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE MULTIFIX ANCHOR DID NOT GET DEPLOYED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN AN ADDITIONAL DRILLED HOLE. THE PATIENT IS HEALTHY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24176826 ↗
• MalfunctionJan 23, 2026Fracture

  IT WAS REPORTED THAT DURING A SURGERY, ONE (1) MULTIFIX ULTRA ANCHOR FRACTURED ON A DENSE BONE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167324 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, WHEN THE SURGEON PUT THE SUTURE ANCHOR IN THE PILOT HOLE THE MULTIFIX ANCHOR BROKE. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878782 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, UPON IMPACTING A MULTIFIX S-ULTRA ANCHOR, THE TIP BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. 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 23656774 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING A REPAIR OF SHOULDER JOINT LIGAMENTS, THE FRONT SIDE OF THE MULTIFIX KNOTLESS ANCHOR BECAME BROKEN DURING THE THREADING PROCESS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618696 ↗
• MalfunctionNov 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HEAD OF A MULTIFIX S-ULTRA 5.5MM ANCHOR BROKE. THE PROCEDURE WAS PERFORMED WITH AN EQUIVALENT SN BACK UP DEVICE, IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565841 ↗
• MalfunctionNov 13, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE THREAD OF THE MULTIFIX S-ULTRA 5.5MM KNOTLESS WAS SLIPPING AND THE FIXING STRENGTH WAS INSUFFICIENT. 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 23544740 ↗
• MalfunctionNov 13, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE MULTIFIX ANCHOR WAS SPLIT WHEN INSERTED. 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 23544618 ↗
• MalfunctionOct 30, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, A MULTIFIX S-ULTRA ANCHOR SUTURES WERE DIFFICULT TO PASS THROUGH THE ANCHOR, AND THEN WHEN THE BLACK KNOB WAS TURNED, THE ENTIRE ANCHOR TWISTED AND THE SUTURES BECAME TWISTED AROUND THE ANCHOR. THE SURGEON ENDED UP CUTTING OUT THE ANCHOR AND ONLY DOING A SINGLE ROW REPAIR, A VOID WAS LEFT IN THE PATIENT. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23424389 ↗
• MalfunctionSep 28, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOTICED THAT THE TIP OF A MULTIFIX S-ULTRA ANCHOR BROKE WHILE THE SURGEON MALLETED IT AT THE HOLE. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FORM THE PATIENT WITH FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23163854 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF A MULTIFIX S-ULTRA ANCHOR BROKE WHILE INSERTION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901389 ↗
• MalfunctionAug 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE MULTIFIX ANCHOR GOT DAMAGED WHILE DEPLOYING AT THE LATERAL ROW. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849436 ↗