BIORAPTOR 72202397Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 03596010651280), received between Nov 3, 2017 and Jul 3, 2025 — classified as 29 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY FOR LABRAL REPAIR, THE SURGEON TRIED TO UNSCREW ONE (1) BIORAPTOR KNOTLESS SUTURE ANCHOR, BUT IT STAYED ON THE HANDLE, AND THEN FALL DOWN FROM THE HANDLE, OUTSIDE OF THE DRILLED BONE HOLE. A SECOND BIORAPTOR KNOTLESS SUTURE ANCHOR FROM THE SAME LOT NUMBER WAS USED IN AN ADDITIONAL BONE HOLE, AND IT PRESENTED THE SAME PROBLEM. THUS, THE SURGEON RESORTED TO USING A ARTHREX 2.4 MM MINI HIP PUSHLOCK PRODUCT. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22391855 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE BIORAPTOR KNOTLESS SUTURE ANCHOR HIP BROKE WHILE BEING IMPLANTED; THE DEVICE WAS REMOVED WITH TWEEZERS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE ON THE ORIGINALLY DRILLED BONE HOLE, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES, NO VOID WAS LEFT IN THE PATIENT, THE PATIENT'S HEALTH CONDITION IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157213 ↗
• MalfunctionFeb 7, 2024Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE BIORAPTOR SUTURE ANCHOR COULD BE DEPLOYED. IT WAS ALSO REPORTED THAT THE ANCHOR BROKE, THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF 15 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659364 ↗
• InjuryDec 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR KNOTLESS SUTURE ANCHOR PULLED OUT AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING AN ADDITIONAL DRILLED BONE HOLE., A VOID WAS LEFT IN THE PATIENT. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18365223 ↗
• InjuryOct 12, 2023Break; Break

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR, TWO BIORAPTOR KNOTLESS ANCHORS FAILED THE SAME WAY. THE INTERNAL ANCHOR SUTURE LOCKING MECHANISM FAILED TO DEPLOY AND BROKE INSIDE OF THE BODY OF THE ANCHOR, THEREFORE, IT WOULD NOT SECURE THE SUTURES AND THE ANCHOR PULLED OUT OF THE BONE. THE PIECES WERE STILL INSIDE THE LARGE BODY OF THE ANCHOR AND PULLED OUT ALONG WITH THE SUTURE. NO PIECES FELL INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 30 MINUTES OF SURGICAL DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE ON AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 17927751 ↗
• InjuryMar 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE INTERNAL PIN WHICH SECURES THE INTERNAL PLUG OF THREE(3) BIORAPTOR KNOTLESS SUTURE ANCHOR HIP BROKE OFF WITHOUT FULLY SECURING THE ANCHOR, AND GOT STUCK IN THE MIDDLE OF THE ANCHOR INSIDE THE PATIENT. BOTH THE ANCHOR AND THE PIN WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A 30-MINUTE SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492028 ↗
• InjuryOct 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE TIP OF THE BIORAPTOR ANCHOR BROKE OFF UPON INSERTION. THE ANCHOR WAS SUCCESSFULLY REMOVED WITH A GRASPER. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581789 ↗
• InjuryAug 8, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AT THE MOMENT OF IMPACTING THE BIORAPTOR KNOTLESS ANCHOR, IT BROKE AROUND THE PREVIOUS PERFORATION PERFORMED, IT IS IMPORTANT TO MENTION THAT THE FORCE USED WHEN IMPACTING WAS MORE THAN NECESSARY. THE REMAINS OF THE IMPLANT WERE REMOVED. THERE WAS NO DAMAGE TO PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183544 ↗
• InjuryFeb 8, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, WHEN THE BIORAPTOR ANCHOR WAS DEPLOYED IT LEFT BEHIND A BIT OF METAL IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 1 HOUR USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 13480680 ↗
• InjuryNov 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY AND LABRAL REPAIR, THE BIORAPTOR ANCHOR WAS PULLED OUT AFTER IMPLANTATION. THE SURGICAL TECHNIQUE USED IN THIS PROCEDURE WAS: 2.9MM DRILL AND DRILL GUIDE, ANCHOR INSERTED WITH MALLET. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846216 ↗
• InjuryNov 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING HIP ARTHROSCOPY PROCEDURE, THE TIP OF THE BIORAPTOR KNOTLESS SUTURE ANCHOR SNAPPED UPON IMPLANTATION. HOWEVER, THE ANCHOR WAS IMPLANTED CORRECTLY. THE BROKEN TIP OF THE INSERTER WAS REMOVED FROM THE PATIENT, ALL MATERIAL WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12774559 ↗
• InjuryAug 15, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN A HIP ARTHROSCOPY W/LABRAL REPAIR, THE SURGEON IMPLANTED 4 BIORAPTOR KNOTLESS ANCHORS. 3 OF THE 4 BROKE. ON THE FIRST IMPLANT, THE INNER LOCKING PLUG WAS NOT SENT ALL THE WAY DOWN TO LOCK THE SUTURE. ON THE NEXT TWO, THE INNER METAL MECHANISM THAT SENDS THE PLUG DOWN, BROKE OFF IN THE BODY OF THE ANCHOR. THE SURGEON WAS ABLE TO USE A GRASPER TO GRAB THE METAL PIECE, AND REMOVE IT FROM THE PATIENT. THE PATIENT OUTCOME IS GOOD. A DELAY LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322435 ↗
• InjuryAug 15, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN A HIP ARTHROSCOPY W/LABRAL REPAIR, THE SURGEON IMPLANTED 4 BIORAPTOR KNOTLESS ANCHORS. 3 OF THE 4 BROKE. ON THE FIRST IMPLANT, THE INNER LOCKING PLUG WAS NOT SENT ALL THE WAY DOWN TO LOCK THE SUTURE. ON THE NEXT TWO, THE INNER METAL MECHANISM THAT SENDS THE PLUG DOWN, BROKE OFF IN THE BODY OF THE ANCHOR. THE SURGEON WAS ABLE TO USE A GRASPER TO GRAB THE METAL PIECE, AND REMOVE IT FROM THE PATIENT. THE PATIENT OUTCOME IS GOOD. A DELAY LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322431 ↗
• InjuryAug 15, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN A HIP ARTHROSCOPY W/LABRAL REPAIR, THE SURGEON IMPLANTED 4 BIORAPTOR KNOTLESS ANCHORS. 3 OF THE 4 BROKE. ON THE FIRST IMPLANT, THE INNER LOCKING PLUG WAS NOT SENT ALL THE WAY DOWN TO LOCK THE SUTURE. ON THE NEXT TWO, THE INNER METAL MECHANISM THAT SENDS THE PLUG DOWN, BROKE OFF IN THE BODY OF THE ANCHOR. THE SURGEON WAS ABLE TO USE A GRASPER TO GRAB THE METAL PIECE, AND REMOVE IT FROM THE PATIENT. THE PATIENT OUTCOME IS GOOD. A DELAY LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322430 ↗
• InjuryJun 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY USING THE BIORAPTOR, METAL PIECES OF THE ANCHOR INSERTER BROKE OFF AFTER LOADING UPON REMOVAL FROM THE PATIENT. THE BROKEN PIECES WERE RETRIEVED USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. COMPLAINT 1 OF 2. REFERENCE (B)(4) (MDR 1219602-2021-01318) FOR RELATED COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963769 ↗
• InjuryJun 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE IRON PIECES OF THE BIORAPTOR ANCHOR BROKE WHILE LOADING AND TRYING TO RETRIEVE THE DEVICE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT BY USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963768 ↗
• InjuryMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, INTERNAL TO THE PATIENT, THE TIP OF THE INSERTER WAS PLACED INTO THE PATIENT´S BONE. IT BROKE OFF. THE TIP WASN¿T REMOVED AND WAS KEPT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO ADDITIONAL DEVICE WAS REQUIRED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11823070 ↗
• InjuryMay 6, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT DURING RIGHT HIP GLENOID LIP REPAIR SURGERY, THE INNER PLUG COULD NOT BE LOCKED WITH THE BIORAPTOR KNOTLESS SUTURE ANCHOR. A BACKUP DEVICE WAS USED IN ADDITIONAL BONE HOLE AND NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11782701 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, DURING THE PLACEMENT OF THE BIORAPTOR KNOTLESS SUTURE ANCHOR HIP ONCE THE SHAFT WAS REMOVED FROM THE ANCHOR IT WAS NOTICED THAT THE INTERNAL SCREW THAT BLOCKS THE ANCHOR DID NOT COME OUT. BY A RX, IT WAS NOTICED THAT THE SCREW WAS INSIDE THE INTERNAL STRUCTURE OF THE ANCHOR. THE METAL PIECE COULD NOT BE REMOVED OUT FROM THE PATIENT. PATIENT HEALTH CONDITION IS STABLE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IS THERE WAS ANY DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588795 ↗
• MalfunctionJan 8, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT WHEN SCRUB NURSE BEGAN OPENING THE BIORAPTOR KNOTLESS ANCHOR, NOTICED THE STERILE PACKAGING WAS IMPAIRED, TWO SMALL HOLES WERE NOTICED IN PACKAGING. UNSTERILE ANCHOR WAS NOT OPENED AND OTHER NEW BIORAPTOR KNOTLESS ANCHOR WAS OPENED WITHOUT ISSUE. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140297 ↗
• MalfunctionJan 8, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT WHEN SCRUB NURSE BEGAN OPENING THE BIORAPTOR KNOTLESS ANCHOR, NOTICED THE STERILE PACKAGING WAS IMPAIRED, TWO SMALL HOLES WERE NOTICED IN PACKAGING. UNSTERILE ANCHOR WAS NOT OPENED AND OTHER NEW BIORAPTOR KNOTLESS ANCHOR WAS OPENED WITHOUT ISSUE. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140293 ↗
• InjuryJan 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY WHILE USING BIORAPTOR KNOTLESS SUTURE ANCHOR, THE MECHANISM BROKE AND WAS SEPARATED FROM THE ANCHOR. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED AND IF THERE WERE DELAYS. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11132226 ↗
• InjuryJan 6, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY +LABRAL REPAIR, THE BIORAPTOR KNOTLESS ANCHOR BROKE OFF WHILE IT WAS BEING INSERTED INTO THE DRILLED TUNNEL. THERE WAS A SURGICAL DELAY BETWEEN 31-60 MINUTES. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL THE BROKEN PIECES WERE REMOVED USING A GRASPER. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128850 ↗
• InjuryJan 6, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY +LABRAL REPAIR, THE BIORAPTOR KNOTLESS ANCHOR BROKE OFF WHILE IT WAS BEING INSERTED INTO THE DRILLED TUNNEL. THERE WAS A SURGICAL DELAY BETWEEN 31-60 MINUTES. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL THE BROKEN PIECES WERE REMOVED USING A GRASPER. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128842 ↗
• InjuryJan 6, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY +LABRAL REPAIR, THE BIORAPTOR KNOTLESS ANCHOR BROKE OFF WHILE IT WAS BEING INSERTED INTO THE DRILLED TUNNEL. THERE WAS A SURGICAL DELAY BETWEEN 31-60 MINUTES. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL THE BROKEN PIECES WERE REMOVED USING A GRASPER. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128841 ↗