Quattro® Link Knotless Anchor CM-9129Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887868270161), received between Jul 12, 2021 and Jul 13, 2023 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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.

• InjuryJul 13, 2023Fracture; Fracture

  ADDING NOTE FOR THERE BEING AN INSERTER THE WAS FRACTURED AND RETAINED ALONG WITH THE ANCHOR FRACTURED AND RETAINED. IT IS NOTED THAT IT IS UNKNOWN WHICH LOT WAS FRACTURED AND RETAINED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17317345 ↗
• InjuryJul 13, 2023Fracture; Fracture

  ADDING NOTE FOR THERE BEING AN INSERTER THE WAS FRACTURED AND RETAINED ALONG WITH THE ANCHOR FRACTURED AND RETAINED. IT IS NOTED THAT IT IS UNKNOWN WHICH LOT WAS FRACTURED AND RETAINED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17317286 ↗
• InjuryJul 13, 2023Fracture; Fracture

  ADDING NOTE FOR THERE BEING AN INSERTER THE WAS FRACTURED AND RETAINED ALONG WITH THE ANCHOR FRACTURED AND RETAINED. IT IS NOTED THAT IT IS UNKNOWN WHICH LOT WAS FRACTURED AND RETAINED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17317271 ↗
• MalfunctionNov 8, 2022Fracture; Fracture

  IT WAS REPORTED DURING SURGERY ON THE RIGHT SIDE OF THE PATIENT, WHILE MALLEATING IN THE ANCHOR, THE TIP OF THE ANCHOR BROKE IN HALF. ANCHOR WAS REMOVED AND ADDITIONAL 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 15750943 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS UNPACKED AND AFTER FINDING THE DEFECT, IT WAS NOT USED FOR THE PROCEDURE. A SECOND IMPLANT WAS USED TO COMPLETE THE PROCEDURE. FROM REPORTED PHOTOS, THE REPORTED DEVICE LOOKS FRACTURED. 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 15536305 ↗
• MalfunctionMar 19, 2022Fracture; Fracture

  IT WAS REPORTED DURING A RIGHT ROTATOR CUFF SURGERY WITH BICEPS TENODESIS PROCEDURE, THE ANCHOR BROKE IN HALF, ANCHOR PLACEMENT WAS MOVED TO ANOTHER SPOT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13823810 ↗
• MalfunctionMar 2, 2022Fracture; Fracture

  IT WAS REPORTED DURING ROTATOR CUFF REPAIR SURGERY, THE TIP OF THE ANCHOR BROKE DURING IMPLANTATION. ALL PIECES WERE RETRIEVED AND ANOTHER IMPLANT 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 13651733 ↗
• MalfunctionFeb 4, 2022Fracture; Fracture

  IT WAS REPORTED DURING A RIGHT ROTATOR CUFF SURGERY WITH BICEPS TENODESIS PROCEDURE, THE ANCHOR BROKE IN HALF, ANCHOR PLACEMENT WAS MOVED TO ANOTHER SPOT. 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 13451032 ↗
• MalfunctionFeb 4, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451029 ↗
• MalfunctionJan 13, 2022Separation Failure; Separation Failure

  IT WAS REPORTED DURING SURGERY ON THE RIGHT SIDE OF THE PATIENT, THE DEVICE CAME APART LEAVING THE CENTER ROD STUCK ON THE IMPLANT. SURGEON USED A NEEDLE DRIVER AND MALLET TO REMOVE AND THE IMPLANT CAME OUT ON ITS OWN. 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 13249988 ↗
• InjuryOct 25, 2021Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 12689462 ↗
• MalfunctionJul 12, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150649 ↗
• MalfunctionJul 12, 2021Fracture; Fracture

  UPON RECEIPT OF THIS DEVICE, IT IS NOW DETERMINED TO BE NOT REPORTABLE. NO SERIOUS INJURY OR HARM TO THE PATIENT REPORTED FOR THIS EVENT OR PRIOR EVENTS WITH SAME OR SIMILAR PRODUCTS. THE INITIAL REPORT SHOULD BE VOIDED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150643 ↗