BIORAPTORRecalls & reported problems across all models

We found 12 models of BIORAPTOR by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 262 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Jun 25, 2026 — classified as 82 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Break” (157 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

BIORAPTOR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 4 of these models · Recall details · FDA record ↗

Most reported BIORAPTOR problems

BIORAPTOR models

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

• BIORAPTOR 72202403

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  127 reports
• BIORAPTOR 72201541

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 recall41 reports
• BIORAPTOR 72203281

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 recall13 reports
• BIORAPTOR 72202397

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  61 reports
• BIORAPTOR 72201542

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 recall3 reports
• BIORAPTOR 72203280

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 recall3 reports
• BIORAPTOR 72201108

  ACCESSORIES,ARTHROSCOPIC
  5 reports
• BIORAPTOR 72201395

  SAW, POWERED, AND ACCESSORIES
  4 reports
• BIORAPTOR 72201543

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  2 reports
• BIORAPTOR 72201391

  ACCESSORIES,ARTHROSCOPIC
  1 report
• BIORAPTOR 72201389

  ACCESSORIES,ARTHROSCOPIC
  1 report
• BIORAPTOR 72202404

  ACCESSORIES,ARTHROSCOPIC
  1 report

Recent BIORAPTOR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, ONE (1) BIORAPTOR SUTURE ANCHOR WAS BROKEN. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617114 ↗
• MalfunctionJun 3, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE OF THE BIORAPTOR BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT BY SUCTION AND TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386231 ↗
• 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 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A REPAIR OF THE LATERAL COLLATERAL LIGAMENT OF THE ANKLE, TWO (2) BIORAPTOR ANCHORS WERE PULLED OUT. THE PROCEDURE WAS RESUMED, WITH A SIGNIFICANT DELAY, USING A KEYIBANGEN COMPETITOR DEVICE. THE DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID IN THE PATIENT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS AN ANCHOR MATCHING INSTRUMENT AND THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410884 ↗
• 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 ↗
• MalfunctionJan 8, 2026Break

  DURING A HIP ARTHROSCOPY PROCEDURE, THE 2.6 MM BIORAPTOR DRILL BIT BROKE INSIDE THE PATIENT. A REPLACEMENT DEVICE FROM A COMPETITOR (ARTHREX) WAS USED TO CONTINUE THE PROCEDURE. THE SURGERY WAS DELAYED FOR MORE THAN AN HOUR WHILE ALL FRAGMENTS OF THE BROKEN DRILL BIT WERE LOCATED AND REMOVED. THE BROKEN PIECES WERE REMOVED USING A DISC CLAMP (3 MM DIAMETER). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003213 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• InjuryJun 12, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, AFTER DRILLING THE BONE, THE TIP OF A BIORAPTOR DRILL WAS MISSING. LOOKING UNDER X-RAY, IT WAS NOTICED THAT THE TIP WAS IN THE BONE. IT COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT'S BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS A DELAY OF 20 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22199915 ↗
• 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 ↗

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