RAPTORMITE / ULTRABRAIDRecalls & reported problems across all models

We found 2 models of RAPTORMITE / ULTRABRAID by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2018 and May 11, 2026 — classified as 17 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. 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

Most reported RAPTORMITE / ULTRABRAID problems

RAPTORMITE / ULTRABRAID models

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

• RAPTORMITE / ULTRABRAID 72201806

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  22 reports
• RAPTORMITE / ULTRABRAID 72201805

  Screw, fixation, bone
  1 report

Recent RAPTORMITE / ULTRABRAID adverse event reports

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

• MalfunctionMay 11, 2026Crack

  IT WAS REPORTED THAT, DURING AN ELBOW JOINT REDUCTION AND INTERNAL FIXATION SURGERY, THE RAPTORMITE ANCHOR'S SIDE CRACKED AFTER IMPLANTING IT, ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145219 ↗
• MalfunctionMay 11, 2026Fracture

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) RAPTORMITE ULTRABRAID FRACTURED WHEN IT WAS BEING IMPLANTED. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142168 ↗
• MalfunctionMar 14, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE RAPTORMITE IMPLANT TOOK OUT FROM THE IMPLANT BOX INSERT TO PATIENT BONE, THE ANCHOR SUTURE VERY SOFT AND BEND AND DIFFICULT TO INSERT REPAIR. IT WAS LIKE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909630 ↗
• InjuryFeb 6, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE RAPTORMITE ANCHOR BROKE OFF PREMATURELY FROM THE SETTING INSTRUMENT DURING INSERTION. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT, HOWEVER, IT IS UNKNOWN HOW. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. PATIENT'S CURRENT STATE IS GOOD AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308628 ↗
• InjuryAug 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DISTAL BICEP TEAR REPAIR, AFTER DRILLING TO PLACE THE RAPTORMITE ANCHOR, IT WAS DIFFICULT FOR SURGEON TO SEE WHERE THE HOLE WAS AS HE WAS ALSO RETRACTING TO SEE THE AREA WHERE THE ANCHOR WOULD BE PLACED. THEN, AFTER BEIN PLACED, THE ANCHOR CAME OUT OF THE BONE. AS A RESULT, A NEW BONE HOLE WAS DRILLED AND BACKUP ANCHOR WAS PLACED FOR THE REPAIR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATION WERE REPORTED.

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

  MAUDE report 15195998 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REPAIR LIGAMENT ANKLE WITH FOUR(4) RAPTORMITE ANCHORS (CASE-(B)(4) /LOT #2080566); (CASE-(B)(4) / LOT#2065615); (CASE-(B)(4) /LOT#2078872); (CASE-(B)(4) / LOT#2075624) . THE PATIENT HAD AN UNSPECIFIED ADVERSE REACTION. IT IS UNKNOWN HOW THE EVENT WAS TREATED.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information; Subcutaneous Nodule

  MAUDE report 15169057 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REPAIR LIGAMENT ANKLE WITH FOUR(4) RAPTORMITE ANCHORS ((B)(4) /LOT #2080566); ((B)(4)/ LOT#2065615); ((B)(4) /LOT#2078872); ((B)(4)/ LOT#2075624) . THE PATIENT HAD AN UNSPECIFIED ADVERSE REACTION. IT IS UNKNOWN HOW THE EVENT WAS TREATED.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information; Subcutaneous Nodule

  MAUDE report 15169047 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REPAIR LIGAMENT ANKLE WITH FOUR(4) RAPTORMITE ANCHORS (CASE-2022-00114249-1 /LOT #2080566); (CASE-(B)(4) / LOT#2065615); (CASE-(B)(4) /LOT#2078872); (CASE-(B)(4) / LOT#2075624) . THE PATIENT HAD AN UNSPECIFIED ADVERSE REACTION. IT IS UNKNOWN HOW THE EVENT WAS TREATED.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information; Subcutaneous Nodule

  MAUDE report 15169034 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REPAIR LIGAMENT ANKLE WITH FOUR(4) RAPTORMITE ANCHORS ((B)(4) /LOT #2080566); ((B)(4)/ LOT#2065615); ((B)(4)/LOT#2078872); ((B)(4)/ LOT#2075624) . THE PATIENT HAD AN UNSPECIFIED ADVERSE REACTION. IT IS UNKNOWN HOW THE EVENT WAS TREATED.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information; Subcutaneous Nodule

  MAUDE report 15169029 ↗
• InjuryMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, A RAPTOMITE ANCHOR WAS INSERTED INTO THE HOLE, BUT IT CAME LOOSE WHEN TENSIONING THE SUTURES. IT IS UNKNOWN IF ANOTHER BACKUP ANCHOR WAS USED. NON-SIGNIFICANT DELAYS OCCURRED AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711683 ↗
• InjurySep 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANKLE DELTOID LIGAMENT REPAIR, THE ANCHOR OF RAPTORMITE WAS PULLED OUT AFTER IMPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL DRILLED BONE HOLE. NO OTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 12479103 ↗
• InjuryMay 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING A FOOT AND ANKLE SURGERY, THE RAPTORMITE BROKE WHEN INSERTING THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794512 ↗
• InjuryMar 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING A MCL/LCL LIGAMENT REPAIR, THE ANCHOR BROKE AND IT WAS UNABLE TO BE IMPLANTED ON THE PATIENT, NO LOSE PIECES IN THE PATIENT. INSERTION SITE PREPARED WITH A 2.6 MM DRILL BIT BY SNN. THE PROCEDURE WAS FINISHED WITHOUT SIGNIFICANT DELAY BY CHANGING SURGICAL THE TECHNIQUE TO A TWINFIX TI. 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 11542072 ↗
• InjuryMar 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING A FOOT AND ANKLE REPAIR SURGERY, THE RAPTORMITE ANCHOR BROKE IN THE PROCESS OF HITTING WITH A TURNING MALLET AFTER INSERTING IT. INSERTION SITE HAD BEEN PREPARED WITH A 2.6 MM DRILL, TUNER SIZE 2.6 MM. ALL PIECES REMOVED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516155 ↗
• InjuryFeb 11, 2021Break; Break

  IT WAS REPORTED THAT DURING A WRIST STABILIZATION SURGERY, A HOLE WAS DRILLED AND WHEN THE RAPTORMITE ANCHORS WERE BEING SCREW IN THEY GOT FRACTURED. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL THE BROKEN PIECES WERE REMOVES FROM THE PATIENT'S ANATOMY USING TWEEZERS. NO ADDITIONAL BONE HOLE WAS REQUIRED TO COMPLETE THE SURGERY. 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 11319558 ↗

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