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MICRORAPTOR 72204984Recalls & reported problems

Smith & Nephew, Inc. · MICRORAPTOR REGENESORB SUTURE ANCHOR WITH ONE ULTRABRAID No.1 SUTURE BLUE COBRAID · Class 2 · Implant

All models of MICRORAPTOR (7)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
21
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885556710319), received between Feb 15, 2019 and May 1, 2026 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated7
  • Manufacturing, Packaging or Shipping Problem6
  • Break5
  • Adverse Event Without Identified Device or Use Problem2
  • Expulsion1
  • Positioning Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions9
  • No Patient Involvement6
  • Perforation3
  • Rupture3
  • No Known Impact Or Consequence To Patient2
  • Foreign Body In Patient1
  • No Information1
  • Pain1

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 1, 2026Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING SURGERY, AFTER ONE (1) MICRORAPTOR REGENESORB WAS INSERTED INTO THE BONE HOLE AND THE SUTURE WAS PERFORMED, THE ANCHOR PULLED OUT. THE ANCHOR COULD NOT BE REMOVED FROM THE JOINT. IT WAS LEFT WITHIN THE BONE HOLE AND SOFT TISSUE. THE PROCEDURE WAS RESUMED, AFTER ONE HOUR DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Foreign Body In Patient; Perforation

    MAUDE report 25058635 ↗
  • MalfunctionApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING AN INSTABILITY SLAP REPAIR, AFTER INTRODUCING THE MICRORAPTOR REGENESORB ANCHOR, WHEN THE SURGEON TIED THE SUTURE ON THE LABRUM TISSUE THE ANCHOR PULLED OUT FROM THE BONE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19067240 ↗
  • MalfunctionNov 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE MICRORAPTOR ANCHOR CAME OFF AFTER IMPLANTATION WHEN TYING KNOT. 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 18215918 ↗
  • MalfunctionSep 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE MICRORAPTOR SUTURE ANCHOR CAME OFF AFTER IT WAS IMPLANTED USING A CURVED GUIDE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17814831 ↗
  • InjurySep 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING SLAP REPAIR WITH A SHOULDER ARTHROSCOPY, THE ANCHOR OF THE MICRORAPTOR KNOTTED REGENESORB WAS PULLED OUT WHEN TIGHTENING THE KNOTS. THE ANCHOR WERE SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A MICRORAPTOR KNOTLESS AND A Q-FIX USED IN THE ADDITIONALLY DRILLED BONE HOLE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

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

    MAUDE report 17684854 ↗
  • InjurySep 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING A GLENOID LABRUM REPAIR SURGERY, A TOTAL OF TWO (2) MICRORAPTOR ANCHORS CAME OFF FROM THE BONE HOLE WHEN THEY WERE DEPLOYED AND WHILE KNOT TYING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A COMPETITOR DEVICE (ZIMMER, JUGGERKNOT 1.4, SURELOCK 2.2). IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE. THERE WAS NON-SIGNIFICANT SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Rupture

    MAUDE report 15513047 ↗
  • InjuryAug 8, 2022Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE MICRORAPTOR ANCHOR CAME OFF. IT IS UNKNOWN HOW THE ISSUE WAS SOLVER AND A NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

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

    MAUDE report 15183826 ↗
  • InjuryFeb 14, 2022Break; Break

    IT WAS REPORTED THAT DURING A LABRUM REPAIR PROCEDURE, A MICRORAPTOR REGENESORB ANCHOR BROKE AT PROXIMAL 1/3 OF THE ANCHOR WHEN TYING KNOTS OVER THE TISSUE. THE SURGEON HAD TO REVERT TO MITEK GRYPHON ANCHOR AND ARTHREX PUSHLOC TO SECURE THE LOOSE THREADS IN THE LABRUM, DRILLING NEW BONE HOLES. THE ANCHOR BIT WERE REMOVED FROM THE PATIENT AND A SURGICAL DELAY GREATER THAN 60 MINUTES WAS REPORTED. SMALL VOID WAS LEFT IN THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED.

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

    MAUDE report 13529083 ↗
  • InjuryOct 15, 2021Break; Break

    IT WAS REPORTED THAT DURING AN INSTABILITY SURGERY, THE MICRORAPTOR REGENSORB SUTURE ANCHOR BROKE DURING DEPLOYMENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12637625 ↗
  • InjuryMay 14, 2021Expulsion; Expulsion

    IT WAS REPORTED THAT DURING THE SURGERY, AFTER THE MICRORAPTOR ANCHOR WAS DEPLOYED IN THE BONE HOLE AND IT WAS BEING KNOTTED IT GOT RELEASED EASILY AND FELL OFF. NO PATIENT INJURIES OR DELAY REPORTED. UNKNOWN HOW THE SURGERY WAS COMPLETED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11828415 ↗
  • InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A RIGHT SHOULDER ARTHROSCOPIC SURGERY ASSOCIATED WITH THE USE OF A "MICRORAPTOR REGENESORB SUTURE ANCHOR (UB II # 1 STR BL CB)"; THE PATIENT EXPERIENCED A RIGHT SHOULDER ADHESIVE CAPSULITIS, TO TREAT THE ADVERSE EVENT, THE PATIENT UNDERWENT FOR A SHOULDER ARTHROSCOPIC LYSIS OF ADHESION, EXTENSIVE DEBRIDEMENT, AND SUBACROMIAL DECOMPRESSION. THE PATIENT OUTCOME IS RESOLVING. 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 11333428 ↗
  • MalfunctionNov 20, 2020Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY STABILIZATION, THE DEPTH OF THE "MICRORAPTOR DRILL (1,6MM)" IN BONE WHEN CROSSING THE CARTILAGE WAS NOT DEEP ENOUGH TO ANCHOR WELL THE "MICRORAPTOR REGENESORB (SA, UB II, #1 STR BL CB)". THEREFORE, WHEN KNOTTING THE ANCHOR GOT RELEASED EASILY AND HAD TO BE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE OR IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. NO ADDITIONAL 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 Information

    MAUDE report 10879953 ↗
  • InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT BECAUSE OF AN INCREASE IN A SHOULDER PAIN, AN ARTHROSCOPIC ROTATOR CUFF REPAIR WITH LABURM REPAIR REVISION SURGERY WAS CONDUCTED, CONFIRMING THAT MICRORAPTOR ANCHOR HAD NOT FAILED SINCE IT WAS STILL IN THE GLENOID AND IT WAS NOT IN THE JOINT. THE PATIENT OUTCOME IS ONGOING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: Pain

    MAUDE report 10791523 ↗
  • MalfunctionOct 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THE CE MARK OF THE MICRORAPTOR HAD BEEN ADDED ON THE PACKAGING AS A STICKER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10759471 ↗
  • MalfunctionOct 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THE CE MARK OF THE MICRORAPTOR HAD BEEN ADDED ON THE PACKAGING AS A STICKER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10759450 ↗
  • MalfunctionOct 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THE CE MARK OF THE MICRORAPTOR HAD BEEN ADDED ON THE PACKAGING AS A STICKER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10759415 ↗
  • MalfunctionOct 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THE CE MARK OF THE MICRORAPTOR HAD BEEN ADDED ON THE PACKAGING AS A STICKER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10759355 ↗
  • MalfunctionOct 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THE CE MARK OF THE MICROCRATER HAD BEEN ADDED ON THE PACKAGING AS A STICKER. NO CASE REPORTED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10759327 ↗
  • MalfunctionOct 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THE CE MARK OF THE MICRORAPTOR HAD BEEN ADDED ON THE PACKAGING AS A STICKER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10759313 ↗
  • MalfunctionFeb 15, 2019Break

    IT WAS REPORTED THAT DURING SURGERY WHILE INSERTING THE ANCHOR, IT BROKE OFF. THE ANCHOR WAS HELD IN THE BONE BUT THEY HAD TO RETRIEVE A PIECE OF MATERIAL. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8344599 ↗
  • MalfunctionFeb 15, 2019Break

    IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR BROKE UPON INSERTION. TWO ANCHOR BROKE APART WHEN IMPLANTING. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8344581 ↗

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