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MICRORAPTOR 72205020Recalls & reported problems

Smith & Nephew, Inc. · MICRORAPTOR KNOTLESS SA RGNSB · Class 2 · Implant

Quick summary

This Smith & Nephew MicroRaptor Knotless anchor is a biodegradable soft-tissue fixation anchor used to secure sutures in shoulder, knee and ankle arthroscopy. The 37 reports mostly describe the anchor breaking, bending or pulling out of the bone during surgery, sometimes leaving pieces behind that had to be removed, along with a few reports of puncture of nearby tissue. Reports include 22 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
37
Deaths reported
0
Injuries reported
22
Recalls naming it
0

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00885556722510), received between Aug 18, 2020 and Oct 15, 2025 — classified as 22 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (18 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break18
  • Adverse Event Without Identified Device or Use Problem7
  • Device Dislodged or Dislocated3
  • Material Separation2
  • Physical Resistance/Sticking2
  • Component Missing1
  • Detachment of Device or Device Component1
  • Failure to Advance1

Patient problems

  • No Clinical Signs, Symptoms or Conditions21
  • Perforation6
  • Joint Dislocation3
  • Foreign Body In Patient2
  • Pain2
  • Ankylosis1
  • Hemorrhage/Blood Loss/Bleeding1
  • Injury1

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 15, 2025Break; Break

    IT WAS REPORTED THAT DURING AN INSTABILITY SURGERY, IT WAS NOTICED THAT THE MICRORAPTOR KNOTLESS ANCHOR BROKE, WHEN THE SURGEON PUT THE SUTURE ANCHOR IN THE PILOT HOLE. THE PROCEDURE WAS RESUMED, AFTER A DELAY LESS THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23288423 ↗
  • MalfunctionJul 21, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE MICRORAPTOR KNOTLESS WAS BENT ALTHOUGH THE BONE WAS PREPPED CORRECTLY WITH A 2.6MM MRK DRILL AND PLACED INTO THE CORRECT HOLE. IT COULD NOT BE DEPLOYED AND WAS REMOVED USING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACKUP DEVICE ON THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT HAS A HEALTHY STATUS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22552637 ↗
  • MalfunctionJun 30, 2025Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT DURING A MENISCUS RECONSTRUCTION, THE GRAY THREAD OF THREE (3) MICRORAPTOR KNOTLESS IMPLANTS WERE ANCHORED BUT DID NOT ROTATE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE. 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 22359096 ↗
  • MalfunctionJun 13, 2025Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE MICRORAPTOR ANCHOR'S TIP GOT BROKEN WHILE TAPPING INTO THE BONE, THE BROKEN PIECES WERE REMOVED FROM THE BONE WITH THE HELP OF GRASPER. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN AN ADDITIONAL HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 22207870 ↗
  • MalfunctionMay 21, 2025Break; Break

    IT WAS REPORTED THAT DURING A KNEE AND ANKLE ARTHROSCOPY, WHEN INSERTING THE MICROCRATER KNOTLESS ANCHOR, IT WAS INTRODUCED WITHOUT RESPECTING THE APPROPRIATE TUNNEL ANGULATION. DURING FIXATION WITH THE HAMMER, THE ANCHOR BROKE BEFORE REACHING ITS FINAL POSITION, THEREBY COMPROMISING ITS FUNCTIONALITY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22064952 ↗
  • MalfunctionMar 24, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION, THE MICRORAPTOR ANCHOR SKIVED ON THE HARD BONE AND BROKE. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. A VOID WAS LEFT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 21682605 ↗
  • MalfunctionMar 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT, DURING SURGERY, THE MICRORAPTOR KNOTLESS ANCHOR GOT PULLED OUT FROM THE BONE WHILE TENSIONING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 21669944 ↗
  • InjuryJan 2, 2025Break; Break

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, WHEN THE SURGEON WAS INPUTTING THE MICRORAPTOR KNOTLESS ANCHOR IN THE SUPERIOR LABRUM. HE DRILLED OFF AXIS AND THERE WAS POOR BONE QUALITY, SO WHEN HE PUT IN THE ANCHOR HE WENT THROUGH THE ANTERIOR-SUPERIOR CORNER OF THE GLENOID, BROKE OFF THE CORNER OF THE BONE, AND LOST THE ANCHOR'S BODY. THE PEEK TIP AND SUTURE WERE RECOVERED, BUT LOST THE RGSB BODY. THE BODY WAS FULLY INTACT AS WAS LAST SEEN ON THE CAMERA. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Foreign Body In Patient; Periprosthetic fracture

    MAUDE report 21056202 ↗
  • MalfunctionDec 17, 2024Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE MICRORAPTOR ANCHOR BROKE WHILE PUTTING IT INTO THE BONE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20950966 ↗
  • MalfunctionDec 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE INSERTER OF THE MICRORAPTOR KNOTLESS ANCHOR COULD NOT BE TURNED, SO THE IMPLANT DID NOT SEPARATE FROM THE INSERTER AND COULD NOT BE ANCHORED IN THE BONE. A 2.2 MM INSTRUMENT WAS USED TO PREPARE THE INSERTION SITE. THE ANCHOR WAS REMOVED FROM THE PATIENT USING A GRASPING FORCEPS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE FOR THE BACK-UP ANCHOR, AND THERE WAS A DELAY OF LESS THAN 30 MINUTES.

    Patient problems: Perforation

    MAUDE report 20875542 ↗
  • MalfunctionOct 18, 2024Fracture; Failure to Advance; Fracture; Failure to Advance

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN IT WAS TIME TO THREAD THE MICRORAPTOR KNOTLESS ANCHOR IN, IT GOT STUCK. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20481619 ↗
  • MalfunctionAug 27, 2024Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE MICRORAPTOR ANCHOR BROKE WHEN TAPPING INTO THE BONE. THE FRAGMENT WERE REMOVED FROM THE MENISCUS USING A GRASPER. 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 20081386 ↗
  • InjuryMay 7, 2024Component Missing; Component Missing

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN OPENING THE SPLATTER FROM THE PACKAGE OF THE MICRORAPTOR KNOTLESS, THERE WAS NO PART TO ANCHOR, IT WAS NOT FULLY ARMED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY, A BACK-UP DEVICE WAS USED IN A NEW BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Perforation

    MAUDE report 19264169 ↗
  • MalfunctionMar 15, 2024Break; Nonstandard Device; Physical Resistance/Sticking; Break; Nonstandard Device; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE MICRORAPTOR KNOTLESS DID NOT TURN EXCEPT WITH EXCESSIVE FORCE, THE INNER SHAFT WAS LONGER AND THE ANCHOR BROKE INSIDE THE PATIENT'S SHOULDER. NO BROKEN PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18918294 ↗
  • MalfunctionSep 17, 2023Break; Break

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE MICRORAPTOR SNAPPED, ALL PARTS WERE REMOVED FROM PATIENTS HIP. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. BONE QUALITY WAS NORMAL. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. THE SURGEON WAS ULTIMATELY SATISFIED WITH THE SURGICAL OUTCOME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17762324 ↗
  • MalfunctionAug 28, 2023Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE MICRORAPTOR KNOTLESS BROKE OFF WHEN STRUCK. THE TIP WAS REMOVED WITH GRASPING FORCEPS. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS NORMAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17638894 ↗
  • InjuryMay 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER PLACING THE MICRORAPTOR KNOTLESS ANCHOR, AS THE SPECIALIST PERFORMED THE PULL TEST, THE ANCHOR CAME OUT OF THE 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16901669 ↗
  • InjuryFeb 6, 2023Break; Break

    IT WAS REPORTED THAT ON PMCF REVIEW MICRORAPTOR KNOTTED REGENESORB, WAS FOUND THAT DURING A PROCEDURE TO TREAT A SLAP INJURY, WHILE USING ONE (1) MICRORAPTOR KNOTTED REGENESORB AND 1 MICRORAPTOR REGENESORB WITH ONE ULTRABRAID ANCHORS, ONE OF THE ANCHORS DIDN'T WORK AND BROKE OFF BUT IT IS UNKNOWN WHICH ONE. IT IS UNKNOWN HOW WAS THE EVENT TREATED. AFTER THE PROCEDURE THE PATIENT REPORTED POOR COMPLIANCE. PATIENT ALSO HAD CONDITIONS UNRELATED TO THE DEVICES AS MUSCULAR WEAKNESS AND PAIN. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Muscle Weakness/Atrophy; Pain

    MAUDE report 16308029 ↗
  • InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON PMCF REVIEW MICRORAPTOR KNOTTED REGENESORB, ONE (1) PATIENT HAD AN EXCESSIVE BLEEDING 10 MONTHS AFTER A BANKART REPAIR PROCEDURE USING A MICRORAPTOR KNOTTED REGENESORB. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 16282600 ↗
  • InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER AN ARTHROSCOPY PROCEDURE USING A MICRORAPTOR KNOTLESS DEVICE, THE PATIENT EXPERIENCED AN ANKYLOSIS OF RIGHT HIP. A HIP ARTHROSCOPY (LYSIS OF ADHESIONS) WAS SUCCESSFULLY PERFORMED TO TREAT THE PATIENT REPORTED CONDITION.

    Patient problems: Ankylosis

    MAUDE report 15670332 ↗
  • InjurySep 20, 2022Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER THE MICRORAPTOR ANCHOR WAS IMPLANTED INTO THE GLENOID, THE SURGEON WAS UNHAPPY WITH THE FIXATION AND PULLED THE ANCHOR OUT AND RE-INSERTED. THE SURGEON WAS STILL UNHAPPY WITH THE FIXATION THEREFORE PULLED IT OUT AGAIN AND IT BROKE INTO 2 PIECES. THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING AN ALTERNATIVE ANCHOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15457657 ↗
  • InjuryAug 18, 2022Break; Break

    IT WAS REPORTED THAT DURING A LEFT SHOULDER BANKART REPAIR, THE EYELET OF THE MICRORAPTOR KNOTLESS ANCHOR BROKE UPON INSERTION. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED AND IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT, NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15253743 ↗
  • InjuryJul 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER A PERIACETABULAR OSTEOTOMY PROCEDURE USING MICRORAPTOR KNOTLESS, A SERIOUS INJURY WAS EXPERIENCED BY A CLINICAL TRIAL SUBJECT. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15136741 ↗
  • InjuryJul 29, 2022Break; Break

    IT WAS REPORTED THAT DURING A LEFT HIP ARTHROSCOPY AND GLUTEAL REPAIR, DURING THE IMPLANTATION OF TWO (2) MICRORAPTOR KNOTLESS SUTURE ANCHORS, SOME PORTIONS OF THE DEVICES BROKE OFF. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED AND IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENTS, NO FURTHER COMPLICATIONS WERE REPORTED.

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

    MAUDE report 15135997 ↗
  • InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER A CAPSULAR STABILIZATION REPAIR USING THREE MICRORAPTOR ANCHOR, ONE PATIENT HAD A RE-DISLOCATION. PATIENT RECEIVED PT AS TREATMENT. PATIENT OUTCOME IS ONGOING.

    Patient problems: Joint Dislocation

    MAUDE report 13769937 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.