BIORAPTOR 72201541Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 03596010595072), received between Nov 11, 2017 and Dec 11, 2025 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (24 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K071586, K152566, K251627); they may or may not involve this specific model.

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.

Recalls naming this device

1. Oct 29, 2024Open, Classified

   Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

   Z-0581-2025 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, WHEN DEPLOYING THE BIORAPTOR ANCHOR, THE ANCHOR TIP GOT BROKEN WHILE INSERTING IT INTO THE BONE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. A NEW BONE HOLE WAS DRILLED FOR THE BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23780751 ↗
• MalfunctionJul 12, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF THE BIORAPTOR ANCHOR BROKE WHILE PASSING IT THROUGH THE LABRUM, WITH NO KNOWN OBSTRUCTIONS. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22490250 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER TWO (2) BIORAPTOR 2.3 PK ANCHORS WENT INTO THE PATIENT, THE SUTURE BROKE WHEN PASSED THROUGH THE TISSUE. ONE IMPLANT REMAINED EMBEDDED IN THE PATIENTS , AND ONE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21367190 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP SCOPE, AFTER THE ANCHOR WENT INTO THE PATIENT, THE SUTURE BROKE WHEN PASSED THROUGH THE PATIENT TISSUE AND IT RIPPED. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. THE BACK UP DEVICE USED THE ORIGINALLY DRILL BONE HOLE AND ALL THE PIECES WERE RETRIEVED FROM THE PATIENT BY SUCTION AND GRASPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20838994 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR ANCHOR BROKE DURING IMPLANTATION. THE COMPONENT WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087559 ↗
• MalfunctionAug 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR SUTURE ANCHOR GOT PULLED OUT WHEN THE SURGEON PULLED THE SUTURE DURING THE KNOT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE IN AN ADDITIONAL BONE HOLE USING A TWIST DRILL 2.45 MM OF BIORAPTOR TO PREPARE THE INSERTION SITE AND LEAVING A VOID IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS FINE.

  Patient problems: Perforation

  MAUDE report 20046155 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, AFTER THE ANCHOR WENT INTO THE PATIENT, THE SUTURE BROKE WHEN PASSED THROUGH THE PATIENT TISSUE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19818275 ↗
• MalfunctionJul 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SURGERY, THERE WAS NO T AT THE END OF THE SUTURE OF A (1) FAST-FIX 360 (B)(4). ADDITIONALLY, THE SUTURE OF A (1) BIORAPTOR ANCHOR FELL OUT OF THE ANCHOR (B)(4). THE ANCHOR WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764542 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR ANCHOR SNAPPED IN HALF ON INSERTION. THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661396 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF THE BIORAPTOR RUPTURED DURING ANCHOR INSERTION INTRO THE BONE CHANNELS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. ALL PIECES WERE REMOVED FROM THE PATIENT. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE NO FURTHER COMPLICATIONS WERE REPORTED. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620133 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR 2.3 PK ANCHOR BROKE WHEN IT WAS BEING SCREWED. THE ANCHOR WAS REMOVED FROM THE PATIENT. THE SAME BONE HOLE WAS USED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. 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 19032916 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT, DURING A MULTILIGAMENT RECONSTRUCTION, THE BIORAPTOR SUTURE ANCHOR DEVICE FAILED. WHEN THE BIORAPTOR ANCHOR WAS REMOVED FROM THE PACKAGING AND PASSED TO THE ARSENAL BOX, IT PRE-DEPLOYED AND WAS FOUND TO BE BROKEN. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF 15 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660181 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF THE BIORAPTOR EXITED FROM THE ANCHOR DURING BONE FIXATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE. ALL COMPONENTS WERE REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607749 ↗
• MalfunctionSep 24, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREAD OF THE BIORAPTOR ANCHOR BROKE WHEN THE SURGEON TIED THE THREAD AND PULLED THE SUTURE FOR TYING THE KNOT. PART OF THE BROKEN ANCHOR REMAINED INSIDE THE PATIENT BONE AND THE BACK-UP WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 17805199 ↗
• InjuryJul 14, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR SUTURE ANCHOR GOT PULLED OUT FROM THE PILOT HOLE WHEN THE SURGEON TRIED TO MAKE THE KNOT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation; Rupture

  MAUDE report 17329677 ↗
• InjuryJul 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORAPTOR SUTURE ANCHOR BROKE WHILE TAPPING INTO THE BONE. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE HELP OF GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 17278958 ↗
• InjuryMar 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) BIORAPTOR 2.3 BROKE DURING IMPLANTATION. THE SITE WAS PREPARED WITH A TWIST DRILL. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE ON THE ORIGINALLY DRILLED HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497892 ↗
• InjuryAug 2, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF A BIORAPTOR ANCHOR BROKE WHILE PUSHING THE KNOT. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153038 ↗
• InjuryOct 14, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SUTURE PULLED OUT FROM THE ANCHOR POST DEPLOYMENT OF THE ANCHOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636206 ↗
• MalfunctionMar 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP BEFORE THE SURGERY THE BIORAPTOR ANCHOR WAS DEFECTIVE, THE THREAD WAS LOOSE AND THE HEAD OF THE DEVICE WAS MISSING. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A 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 11427454 ↗
• MalfunctionApr 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE BIORAPTOR ANCHOR CAME OUT AFTER THE KNOT WAS PUT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT ANCHOR FRACTURED WHICH MAKES IT A REPORTABLE EVENT. 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 9936506 ↗
• MalfunctionMar 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE ANCHOR BROKE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. 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 9815089 ↗
• MalfunctionMar 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BANKART THE BIORAPTOR 2.3 PK SUTURE ANCHOR CAME OUT AFTER PLACING THE KNOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. AN ADDITIONAL BONE HOLE WAS PERFORMED IN ORDER TO PLACE THE BACK-UP DEVICE. NO PATIENT INJURY 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: No Known Impact Or Consequence To Patient

  MAUDE report 9795237 ↗
• MalfunctionNov 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN INSTABILITY PROCEDURE THE BIORAPTOR 2.3 PK SUTURE ANCHOR CAME OUT. BACK UP DEVICE WAS USE IN ADDITIONAL BONE HOLE TO COMPLETED THE PROCEDURE WITHOUT DELAY. NO PATIENT INJURY 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: No Known Impact Or Consequence To Patient

  MAUDE report 9347613 ↗
• MalfunctionAug 5, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY THE SCREW BROKE INTO PIECES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES. IT IS UNKNOWN IF THERE WAS A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8862827 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071586, K152566, K251627. One submission often covers many models, so check the product and lot details in each record.

• Z-1273-2020 · Dec 30, 2019 · Terminated
  TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.