Quattro® Link Knotless Anchor CM-9155Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887868270222), received between May 4, 2020 and Feb 17, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE ANCHOR OF THE DEVICE FRACTURED INTRA-OPERATIVELY AND A BACKUP PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE ANCHOR WAS REPORTED TO HAVE FRACTURED EASILY. THERE WERE NO REMAINS OF THE FRACTURED ANCHOR RETAINED IN THE PATIENT'S BODY. THE EVENT RESULTED IN APPROXIMATELY UP TO 15 MINUTES OF SURGICAL DELAY DUE TO PREPARATION OF THE BACKUP PRODUCT. THE PATIENT HAD NO CONSEQUENCES OR IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366134 ↗
• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE ANCHOR FRACTURED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO FRAGMENTS WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365904 ↗
• MalfunctionDec 1, 2025Fracture; Fracture

  DURING INTRAOPERATIVE SETUP AND IMPLANTATION, THE ANCHOR DISENGAGED/PULLED OUT WHILE THE IMPLANT WAS BEING DEPLOYED. PROVIDED PHOTOS IDENTIFIED THAT THE ANCHOR IS ALSO FRACTURED. NO ADDITIONAL DETAILS WERE PROVIDED REGARDING THE SPECIFIC PROCEDURE, INTRAOPERATIVE FINDINGS, CORRECTIVE ACTIONS TAKEN, OR WHETHER A REPLACEMENT DEVICE WAS USED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681258 ↗
• MalfunctionJul 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THE COMPLAINT PRODUCT WAS FRACTURED DURING USE. THE SAME INCIDENT OCCURRED ON THE 2 SAME PRODUCTS. FORTUNATELY, ALL OF THE FRACTURED ANCHORS COULD BE REMOVED, SO THERE IS NO REMAINS IN THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532827 ↗
• MalfunctionJul 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR OF THE COMPLAINT PRODUCT WAS FRACTURED DURING USE. THE SAME INCIDENT OCCURRED ON THE 2 SAME PRODUCTS. FORTUNATELY, ALL OF THE FRACTURED ANCHORS COULD BE REMOVED, SO THERE IS NO REMAINS IN THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532817 ↗
• MalfunctionMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR, THE DOCTOR TRIED TO DEPLOY THE LATERAL ROW ANCHOR, BUT THE ANCHOR FRACTURED AND WAS PULLED OUT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310031 ↗
• MalfunctionJan 16, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521849 ↗
• InjuryJun 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE BROKEN ANCHOR TIP WAS LEFT IN THE PATIENT'S BODY. NO FURTHER ADDITIONAL EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130728 ↗
• InjuryNov 23, 2022Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED DURING A ROUTINE MEDICAL CHECKUP AFTER INITIAL SURGERY OF AN ARTHROSCOPIC ROTATOR CUFF REPAIR, PATIENT REPORTED PAIN AT OPERATED SITE. AN MRI WAS PREFORMED AND REPORTED ANCHOR WAS ABOUT TO COME OUT FROM THE IMPLANTATION SITE AND REVISION WAS PERFORMED APPROXIMATELY 3 MONTHS AFTER INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15852768 ↗
• MalfunctionSep 20, 2022Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459139 ↗
• MalfunctionSep 9, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED DURING SURGERY, A FOREIGN SUBSTANCE THAT LOOKS LIKE DUST WAS FOUND INSIDE OF THE STERILE PACKAGE. PRODUCT WAS NOT USED AND A BACKUP PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391080 ↗
• MalfunctionJul 6, 2022Fracture; Fracture

  IT WAS REPORTED SURGERY THAT THE ANCHOR SCREW HAS BROKEN DURING INSERTION IN SHOULDER. ANOTHER ANCHOR WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14938250 ↗
• InjuryMay 4, 2020Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO ANCHOR MIGRATION. IT WAS ALSO REPORTED BY THE HCP THAT THERE WAS NOTHING WRONG WITH THE DEVICE. NO OTHER PATIENT HARM WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 10022376 ↗