MULTIFIX 72290002Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556614211), received between Mar 21, 2018 and Sep 19, 2024 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN OPERATION ON (B)(6) 2024 ON A PATIENT´S RIGHT SHOULDER ROTATOR CUFF REPAIR, A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A TOTAL OF SIX (6) MULTIFIX KNOTLESS ANCHOR WERE USED. IT IS UNKNOWN IF THE DEVICES WERE RETRIEVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Sepsis

  MAUDE report 20257264 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN OPERATION ON (B)(6) 2024 ON A PATIENT´S RIGHT SHOULDER ROTATOR CUFF REPAIR, A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A TOTAL OF FOUR(4) MULTIFIX KNOTLESS ANCHOR WERE USED. IT IS UNKNOWN IF THE DEVICES WERE RETRIEVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Sepsis

  MAUDE report 20257140 ↗
• InjuryMay 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE MULTIFIX S-ULTRA ANCHOR GOT PULLED OFF THE BONE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN A NEW DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19401132 ↗
• InjuryNov 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, AFTER HAVING A BICEPS TENODESIS AND ROTATOR CUFF REPAIR INVOLVING A "MULTIFIX S-ULTRA (6.5MM, KNOTLESS ANCHOR)"; THE PATIENT WAS EXPERIENCING WEAKNESS IN HIS SHOULDER. SO, WHEN HE WAS CHECKED BY THE MEDICAL TEAM, THEY SAW THE PROXIMAL HALF OF THE ANCHOR WAS LOOSE WITHIN THE JOINT SPACE. AS A RESULT, THE PATIENT WENT UNDER A REVISION SURGERY, WHICH RESULTED SUCCESSFUL AND THE SHOULDER WAS HEALED WITH NO ADDITIONAL ANCHORS PUT IN PLACE. HOWEVER, THE BROKEN DISTAL END REMAINED IMPLANTED IN THE PATIENT JOINT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10819828 ↗
• InjuryJun 24, 2020Break; Break

  IT WAS REPORTED THAT DURING A SURGERY USING MULTIFIX S-ULTRA 6.5MM KNOTLESS ANCHOR, THE IMPLANT BROKE WHILE INSERTING. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROBLEM WAS SOLVED USING A BACK UP DEVICE AND THERE WAS A DELAY SHORTER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10193020 ↗
• MalfunctionMar 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY PROCEDURE THE ANCHOR WAS WITHOUT CUT "BLUNT" AND WHEN IT WAS USED THE DOCTOR PUSHED THE PRODUCT AND IT BROKE. ALL PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NO DELAY AND NO BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9827516 ↗
• MalfunctionNov 29, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, WHILE TAPPING THE MULTIFIX INTO THE BONE IT BROKE. THE PIECES WERE REMOVED FROM THE PATIENT AND THERE WAS A BACKUP DEVICE AVAILABLE, WHICH WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9392050 ↗
• MalfunctionAug 12, 2019Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING PROCEDURE, AN EXPIRED MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR WAS IMPLANTED IN A PATIENT. THE ANCHOR WAS NOT REMOVED FROM THE PATIENT; THEREFORE, PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY BUT NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8882061 ↗
• MalfunctionJul 12, 2019Expiration Date Error

  IT WAS REPORTED THAT AN EXPIRED DEVICE WAS IMPLANTED INTO A PATIENT. IS UNKNOWN IF A DELAY HAPPENED AND IF A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8786883 ↗
• MalfunctionFeb 26, 2019Break

  IT WAS REPORTED THAT THE ANCHOR BROKE WHEN SURGEON BEGAN TO IMPACT THE ANCHOR INTO THE BONE. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE AND IF THERE WAS A DELAY DUE TO THE DEVICE MALFUNCTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8370886 ↗
• MalfunctionMar 21, 2018Connection Problem

  IT WAS REPORTED THAT THE SCREW WAS STILL ATTACHED AFTER IT DISENGAGED FROM THE IMPLANT. A COMPETITORS IMPLANT (INTERFERENCE SCREW) WAS INSERTED OVER THE EYELET OF THE S&N DEVICE TO LOCK UP THE TENSION AND SECURE THE REPAIR. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358770 ↗