MULTIFIXRecalls & reported problems across all models

We found 3 models of MULTIFIX by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 237 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2017 and Jun 29, 2026 — classified as 106 injuries, 131 malfunctions.

The most frequently reported specific device problem is “Break” (144 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 MULTIFIX problems

MULTIFIX models

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

• MULTIFIX 72290001

  Fastener, fixation, nondegradable, soft tissue
  217 reports
• MULTIFIX 72290002

  Fastener, fixation, nondegradable, soft tissue
  11 reports
• MULTIFIX OM-2300

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  9 reports

Recent MULTIFIX adverse event reports

The 15 most recent reports across all models, 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 ↗

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