MICRORAPTOR 72204983Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885556710302), received between Aug 28, 2018 and Aug 29, 2023 — classified as 12 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryAug 29, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING SLAP REPAIR WITH A SHOULDER ARTHROSCOPY, THE ANCHOR OF TWO (2) MICRORAPTOR KNOTTED REGENESORB WERE PULLED OUT WHEN TIGHTENING THE KNOTS. ALL ANCHORS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A MICRORAPTOR KNOTLESS AND A Q-FIX. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 17646357 ↗
• InjuryJun 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY 3 MICRPTR RGNSRB STR ANCHR PULLED OUT WITH NO REASON FROM THE PATIENT'S BONE HOLE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 17067794 ↗
• 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 REGENESORB WITH ONE ULTRABRAID ANCHOR. 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 16282565 ↗
• InjurySep 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A GLENOID LABRUM REPAIR SURGERY, A MICRORAPTOR ANCHOR CAME OFF FROM THE BONE HOLE WHEN IT WAS 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 15512727 ↗
• InjuryAug 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Rupture

  MAUDE report 15184183 ↗
• InjuryJun 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, TWO (2) MICRORAPTOR REGENESORB ANCHORS FELL OFF THE DISTAL TIP OF THE SHAFTS WHILE BEING INSERTED INTO THE BONE TUNNEL. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY BY CREATING A NEW BONE TUNNEL AND DEPLOYING COMPETITOR ANCHORS. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 14655083 ↗
• 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 13529206 ↗
• InjuryFeb 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER PUTTING IN THE MICRORAPTOR REGENESORB SUTURE ANCHOR, THE IMPLANT PULLED OUT WHEN THE SURGEON WANTED TO ENSURE IT WAS TIGHT; THE IMPLANT WAS REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13448423 ↗
• InjurySep 22, 2021Premature Activation; Unintended Movement; Premature Activation; Unintended Movement

  IT WAS REPORTED THAT, DURING AN INSTABILITY SHOULDER SURGERY, THE "2.0MM MICRORAPTOR REGENESORB SUTURE ANCHOR" HAS PULLED OUT FROM THE INSERTER WHILE DEPLOYING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE INTO THE SAME BONE HOLE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516317 ↗
• InjuryMay 30, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY ARTHROSCOPY PROCEDURE, USING A MICRORAPTOR, AFTER THE ANCHOR WAS IMPLANTED, SUTURE PASS THRU THE SUTURE TO TISSUE TIGHT KNOT, THE IMPLANT WAS BROKEN AND IT WAS NOT STRONG ENOUGH TO BE INSIDE THE BONE IT PULL OUT FROM THE BONE. A MINI OPEN INCISION WAS PERFORMED TO REMOVE THE ANCHOR FROM PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905778 ↗
• InjuryMay 29, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY ARTHROSCOPY, AFTER THE MICRORAPTOR ANCHOR WAS IMPLANTED, IT BROKE. THE IMPLANT WAS NOT STRONG ENOUGH TO BE INSIDE AND IT PULLED OUT FROM THE BONE. THE ANCHOR WAS TAKEN OUT BY CREATING A MINI OPEN INCISION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAT 30 MINUTES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905744 ↗
• InjuryJan 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER AN ACETABULAR LABRUM REPAIR/RECONSTRUCTION WHERE A MICRORAPTOR WAS USED, THE PATIENT HAD CONSTANT PAIN AND A REVISION WAS PERFORMED. THE CONDITION WAS RESOLVED AND NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11232010 ↗
• 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 10758899 ↗
• 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 10758896 ↗
• 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 10758894 ↗
• 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 10758882 ↗
• 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 10758794 ↗
• MalfunctionOct 4, 2018Break

  IT WAS REPORTED THAT THE ANCHOR BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7935321 ↗
• MalfunctionAug 28, 2018Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, ANCHOR BROKE. BROKEN PIECES WERE REMOVED WITH ARTHROSCOPIC GRASPER. NO PROCEDURAL DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7823512 ↗
• MalfunctionAug 28, 2018Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, ANCHOR BROKE. BROKEN PIECES WERE REMOVED WITH ARTHROSCOPIC GRASPER. NO PROCEDURAL DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7823510 ↗
• MalfunctionAug 28, 2018Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, ANCHOR BROKE. BROKEN PIECES WERE REMOVED WITH ARTHROSCOPIC GRASPER. NO PROCEDURAL DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7823506 ↗