BIORAPTOR 72202403Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 03596010651273), received between Apr 6, 2017 and May 31, 2026 — classified as 37 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Break” (72 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Material Integrity Problem

  IT WAS REPORTED THAT, DURING A BANKART REPAIR SURGERY, WHILE DEPLOYING ONE (1) BIORAPTOR KNOTLESS SUTURE ANCHOR, THE IMPLANT GOT DAMAGED. 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 25342871 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, A BIORAPTOR KNOTLESS ANCHOR 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 24354300 ↗
• MalfunctionOct 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE BIORAPTOR KNOTLESS ANCHOR WAS FRACTURED DURING IMPLANTATION. 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 23437143 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SHOULDER ARTHROSCOPY, IN WHICH TWO (2) BIORAPTOR KNOTLESS ANCHOR WERE USED, THE PATIENT HAD A HARD RECOVERY WITH PAIN, STIFFNESS AND "LOCKING" OF THE JOINT. THE PATIENT UNDERWENT THE CORRECT REHABILITATION PROGRAM. RECENTLY, A FOLLOW UP WITH X-RAY IMAGING, SHOWED A METAL PIECE WAS STILL IN THE JOINT, CONNECTED TO THE ANCHOR, WHICH SHOULD BE ONLY IN PEEK MATERIAL. IT LOOKED LIKE THE METAL BAR IN THE INSERTER THAT SCREWS THE INNER SCREW TO LOCK THE SUTURE. THE PATIENT WILL HAVE RE SURGERY IN THE COMING WEEKS, TO TRY TO GET THIS METAL PIECE OUT FROM THE JOINT. PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient; Joint locking; Pain

  MAUDE report 22932579 ↗
• MalfunctionJul 13, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPIC PROCEDURE, THE BIORAPTOR ANCHOR BROKE AT THE MOMENT OF IMPACT. NO FRAGMENTS WERE LEFT ON PATIENT .THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE ON THE ORIGINALLY DRILLED BONE HOLE OF 2.9 MM. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491187 ↗
• MalfunctionJun 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR KNOTLESS SUTURE ANCHOR GOT CUT WHILE PULLING THE SUTURE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22234510 ↗
• MalfunctionJun 6, 2025Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE BIORAPTOR KNOTLESS SUTURE ANCHOR FELL OF WHEN IT WAS BEING IMPLANTED. THE ANCHOR WAS REMOVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE ON THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN PATIENT. THE PATIENT'S HEALTH CONDITION IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157638 ↗
• MalfunctionJun 6, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORAPTOR KNOTLESS SUTURE ANCHOR FRACTURED; THE DEVICE WAS REMOVED WITH THE HELP OF 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 22157259 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ANCHOR OF THE BIORAPTOR BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS 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 21619484 ↗
• MalfunctionFeb 7, 2025Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE RESPECTIVE INITIATION PROCESS WAS CARRIED OUT WITH A 2.9 LANCET THROUGH A CANNULA AS INDICATED BY THE MANUFACTURER. A BIORAPTOR ANCHOR WAS USED, ONE OF THE TIPS WAS LOADED WITH MINITAPE AND THE ANCHOR WAS INTRODUCED. THIS ALSO PRESENTED A LOT OF RESISTANCE. IT WAS REMOVED AND TRIED AGAIN. HOWEVER, IT WAS NOT COMPLETELY INTRODUCED. THE ANCHOR BROKE AND A PORTION REMAINED IN THE HANDLE WHERE IT WAS ASSEMBLED. GIVEN THESE FINDINGS, IT WAS DECIDED TO CHANGE THE SURGICAL TECHNIQUE AND THEREFORE, THE IMPLANTS. THE PROCEDURE WAS 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 21335347 ↗
• MalfunctionFeb 7, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE RESPECTIVE INITIATION PROCESS WAS CARRIED OUT WITH A 2.9 LANCET THROUGH A CANNULA AS INDICATED BY THE MANUFACTURER. A BIORAPTOR CIRCULAR WAS USED. IT WAS ONLY POSSIBLE TO INTRODUCE IT A LITTLE MORE THAN HALFWAY, IT PRESENTED HIGH RESISTANCE AND REACHED A STOP THAT DID NOT ALLOW FIXATION WITH THE INTERNAL SCREW. AN ATTEMPT WAS MADE TO USE IT AS AN ANCHOR POINT, SO THE EXPOSED PART WAS REMOVED. GIVEN THESE FINDINGS, IT WAS DECIDED TO CHANGE THE SURGICAL TECHNIQUE AND THEREFORE, THE IMPLANTS. THE PROCEDURE WAS 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 21335346 ↗
• MalfunctionFeb 7, 2025Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE RESPECTIVE INITIATION PROCESS WAS CARRIED OUT WITH A 2.9 LANCET THROUGH A CANNULA AS INDICATED BY THE MANUFACTURER. A BIORAPTOR ANCHOR WAS USED, ONE OF THE TIPS WAS LOADED WITH MINITAPE AND THE ANCHOR WAS INTRODUCED. THIS ALSO PRESENTED A LOT OF RESISTANCE. IT WAS REMOVED AND TRIED AGAIN. HOWEVER, IT WAS NOT COMPLETELY INTRODUCED. THE ANCHOR BROKE AND A PORTION REMAINED IN THE HANDLE WHERE IT WAS ASSEMBLED. GIVEN THESE FINDINGS, IT WAS DECIDED TO CHANGE THE SURGICAL TECHNIQUE AND THEREFORE, THE IMPLANTS. THE PROCEDURE WAS 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 21335345 ↗
• MalfunctionJan 31, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A BANKART LESION REPAIR PROCEDURE, WHEN THE BIORAPTOR KNOTLESS WAS INSERTED INTO THE BODY AND THE BLUE THREAD WAS LOOSENED, THE ANCHOR BODY COULD NOT BE SEPARATED FROM THE ROD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285038 ↗
• InjuryJan 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE INNER SHAFT OF BIORAPTOR KNOTLESS SUTURE ANCHOR GOT FRACTURED OR SEPARATED. A SUBSEQUENT X-RAY CONFIRMED THAT A PORTION OF THE INNER SHAFT, ALONG WITH THE ANCHOR, REMAINED EMBEDDED IN THE PATIENT'S BONE AND THERE ARE CURRENTLY NO PLANS FOR REVISION SURGERY. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE SINCE THE ANCHOR WAS SUCCESSFULLY IMPLANTED WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21284451 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT, DURING A LEFT SHOULDER ARTHROSCOPY ROTATOR CUFF REPAIR SURGERY, THE BIORAPTOR SUTURE ANCHOR FELL OUT AND BROKE INTO PIECES. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD IN THE ORIGINALLY DRILLED BONE HOLE. 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 21261049 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR SUTURE ANCHOR GOT BROKEN WHILE TAPPING INTO THE BONE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, ANOTHER HOLE WAS MADE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21037489 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE BIORAPTOR KNOTLESS SUTURE ANCHOR TIP GOT BROKEN WHILE IT WAS BEING TAPPED INTO THE BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD; ANOTHER BONE HOLE WAS MADE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20860421 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR SUTURE ANCHOR BROKE. THERE WAS A BACK UP DEVICE AVAILABLE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402705 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR ANCHOR BROKE INSIDE THE PATIENT. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356168 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR KNOTLESS ANCHOR BROKE. THE BROKEN PARTS WERE REMOVED USING A GRASPER THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE DRILLING A NEW BONE HOLE AND LEAVING A VOID IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20349570 ↗
• MalfunctionSep 6, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN PLACING THE BIORAPTOR SUTURE ANCHOR AND IMPACTING THE ANCHOR, IT BENT, PREVENTING IT FROM PERFORMING ITS PROPER FUNCTION. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161218 ↗
• InjuryJun 17, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR KNOTLESS ANCHOR GOT BROKEN WHILE TAPPING INTO THE BONE, THE BROKEN PIECES WERE REMOVED FROM THE MENISCUS WITH THE HELP OF GRASPER, IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19554798 ↗
• MalfunctionDec 22, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORAPTOR ANCHOR BROKE AND DEFORMED WHILE BEING IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383654 ↗
• InjuryDec 14, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR ANCHOR GOT BROKEN WHILE TAPPING INTO THE BONE. THE BROKEN PIECES WERE REMOVED SUCCESSFULLY WITH THE HELP OF A GRASPER. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN AN ADDITIONAL BOLE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18326237 ↗
• MalfunctionNov 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANKLE TENDON SUTURE SURGERY, THE BIORAPTOR KNOTLESS PULLED OUT AFTER IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204697 ↗