RAPTORMITE / ULTRABRAID 72201806Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03596010619082), received between Jun 23, 2018 and May 11, 2026 — classified as 16 injuries, 6 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K071586); 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, 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 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 ↗
• 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 11319491 ↗
• InjuryFeb 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING A LATERAL LIGAMENT RECONSTRUCTION, THE RAPTORMITE NEEDLE HAD A BENDING/BREAKING PROBLEM. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE WITH A DELAY OF LESS THAN OR EQUAL TO 30 MIN. 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 11275544 ↗
• InjuryJul 12, 2020Break; Break

  IT WAS REPORTED THAT DURING A FOOT AND ANKLE SURGERY, THE ANCHOR TIP OF THE RAPTORMITE WAS EXPOSED ON THE INNER PLASTIC SHEET, AND IT WAS FOUND TO BE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10262164 ↗
• MalfunctionAug 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LATERAL COLLATERAL LIGAMENT REPAIR SURGERY THE NAIL BODY ESCAPES FROM BONE. PRODUCT WAS REMOVED AND A BACK-UP WAS USED. NO SIGNIFICANT DELAY REPORTED AND NO PATIENT INJURIES. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS DEVICE BROKE AS IT WAS SUBMITTED TO EXCESSIVE FORCE AND OFF-AXIS INSERTION, WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8880855 ↗
• InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY: ON (B)(6) 2018 THE PATIENT HAD A DEEP ANKLE INFECTION WITH OSTEOMYELITIS, REQUIRING HOSPITAL ADMISSION, PICC LINE, IV ANTIBIOTICS CIPRO AND RIFAMPIN. THE TREATMENT INVOLVED MEDICATION THERAPY, REVISION SURGERY WITH INCISION, DRAINAGE AND A BONE BIOPSY. THE PATIENT IS RECOVERED WITH SEQUELAE.

  Patient problems: Unspecified Infection

  MAUDE report 8741869 ↗
• InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  T WAS REPORTED THAT AFTER SURGERY: ON (B)(6) 2018 THE PATIENT HAD A DEEP ANKLE INFECTION WITH OSTEOMYELITIS, REQUIRING HOSPITAL ADMISSION, PICC LINE, IV ANTIBIOTICS CIPRO AND RIFAMPIN. THE TREATMENT INVOLVED MEDICATION THERAPY, REVISION SURGERY WITH INCISION, DRAINAGE AND A BONE BIOPSY. THE PATIENT IS RECOVERED WITH SEQUEALAE.

  Patient problems: Unspecified Infection

  MAUDE report 8741858 ↗
• MalfunctionApr 5, 2019Break

  IT WAS REPORTED THAT DURING SURGERY, THE ANCHOR HOLE WAS BLOCKED. THE DEVICE BROKE INTO THE PATIENT AND THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT CONSIDERABLE DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487741 ↗
• MalfunctionJun 23, 2018Break

  IT WAS REPORTED THAT THE ANCHOR BROKE. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632577 ↗

Recalls under the same FDA submission

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

• Z-0581-2025 · Oct 29, 2024 · Open, Classified
  BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.