Quattro® Link Knotless Anchor CM-9145Recalls & reported problems
Cayenne Medical, Inc. · Class 2 · Implant
All models of Quattro Link Knotless Anchor (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cayenne Medical Quattro Link Knotless Anchor is a soft tissue fixation anchor used to attach tissue to bone during surgery. The 30 reports mostly describe the anchor breaking or fracturing while being inserted into bone, sometimes leaving fragments that surgeons retrieved and adding surgical delays. One report mentions a fragment remaining in the patient. Reports include 1 death and 5 injuries. There are no recalls naming 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
- 30
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00887868270192), received between Jun 15, 2020 and Dec 31, 2025 — classified as 1 death, 5 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Fracture” (25 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.
Reports received per month
Most reported problems
Device problems
- Fracture25
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Device Embedded In Tissue or Plaque4
- No Code Available3
- Failure of Implant2
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 31, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR BROKE DURING INSERTION INTO BONE. INTRA-OPERATIVELY, ALL FRAGMENTS WERE RETRIEVED AND NO FRAGMENTS REMAINED IN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934550 ↗MalfunctionDec 17, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE ANCHOR BROKE DURING USE. DURING INTRA-OPERATIVE USE, THE SURGEON CONFIRMED NO PRODUCT-RELATED FRAGMENTS REMAINED IN THE PATIENT AND PROCEEDED WITH A BACKUP PRODUCT, RESULTING IN APPROXIMATELY UP TO 15 MINUTES OF SURGICAL DELAY DUE TO PREPARATION. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827702 ↗MalfunctionJul 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR OF THE PRODUCT WAS FRACTURED. THERE WAS NO REPORT OF A FOREIGN BODY RETAINED OR HARM TO THE PATIENT. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22510247 ↗MalfunctionJul 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR OF THE PRODUCT WAS FRACTURED. THERE WAS NO REPORT OF A FOREIGN BODY RETAINED OR HARM TO THE PATIENT. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22510241 ↗MalfunctionJan 26, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21237258 ↗MalfunctionNov 13, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL FIXATION PROCEDURE, THE ANCHOR DEVICE FRACTURED WHILE BEING INSERTED INTO THE BONE. THERE WAS A TEN (10) MINUTE SURGICAL DELAY TO RETRIEVE A NEW ANCHOR AND THE BROKEN FRAGMENTS HOWEVER NO PATIENT IMPACT OR ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20677756 ↗MalfunctionOct 10, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416652 ↗MalfunctionMay 28, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR PROCEDURE, THE PEEK BODY OF ANCHOR FRACTURED IN HALF WITH LIGHT IMPACTION. DEVICE WAS BEING USED CORRECTLY BY THE SURGEON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 19403787 ↗MalfunctionDec 27, 2023Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR FRACTURED. THERE WAS NO REPORTED PATIENT INJURY 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 18399081 ↗MalfunctionOct 31, 2023Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR FRACTURED DURING THE SURGERY. THE SURGEON REMOVED IMPLANT AND USE A NEW PRODUCT TO FINISH THE SURGERY. 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 18041317 ↗MalfunctionAug 4, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS FRACTURED WHILE THE SURGEON TRIED TO IMPLANT THE ANCHOR INTO THE PATIENT'S BURR HOLE. THE FRACTURED ANCHOR COULD BE REMOVED FROM THE PATIENT'S BODY. ANOTHER DEVICE 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 17458116 ↗MalfunctionApr 24, 2023Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR BROKE AT EYELET. 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 16795872 ↗MalfunctionApr 20, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE ANCHOR CHIPPED. ALL FRAGMENTS WERE ABLE TO BE REMOVED. 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 16775701 ↗MalfunctionDec 20, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED DURING SURGERY THAT TWO ANCHORS WERE BENT AND NOT DISENGAGING PROPERLY. 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 16019481 ↗MalfunctionDec 20, 2022Material Twisted/Bent; Material Twisted/Bent
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16018740 ↗MalfunctionOct 25, 2022Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15665642 ↗MalfunctionAug 12, 2022Fracture; Fracture
IT WAS REPORTED DURING SURGERY, A CRACK WAS GENERATED ON THE ANCHOR WHILE SURGEON WAS ADJUSTING THE TENSION TO THE SUTURE AFTER THE ANCHOR WAS ADVANCED TO THE DISTAL EDGE OF THE FIRST MARKER BAND. ANCHOR WAS REMOVED AND BACKUP WAS USED TO COMPLETE THE SURGERY. 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 15216320 ↗MalfunctionJan 21, 2022Separation Failure; Separation Failure
IT WAS REPORTED DURING SURGERY, THE ANCHOR FAILED TO DETACH FROM INSERTION DEVICE. A REPLACEMENT WAS OPENED. NO ADVERSE EVENT OR PATIENT HARM REPORTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315891 ↗MalfunctionSep 27, 2021Fracture; Fracture
IT WAS REPORTED THAT WHEN THE ANCHOR WAS BEING IMPACTED INTO BONE, THE ANCHOR FRACTURED AND CAME APART IN TWO PIECES. ALL PIECES RETRIEVED, SURGERY WAS COMPLETED WITH ANOTHER DEVICE. 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 12537394 ↗InjuryAug 4, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR FRACTURED WHILE THE SURGEON TRIED TO IMPLANT IT. THE FRACTURED PIECE OF THE ANCHOR REMAINS IN THE PATIENT'S BONE. ANOTHER ANCHOR WAS USED TO COMPLETE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 12275329 ↗MalfunctionMay 12, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11813463 ↗MalfunctionMay 12, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11813460 ↗MalfunctionApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11739898 ↗InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 11731713 ↗MalfunctionJan 29, 2021Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY THREE (3) WEEKS AGO DURING A ROTATOR CUFF REPAIR, THE TIP OF THE ANCHOR BROKE WHILE THE SURGEON WAS ADVANCING THE AWL. PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THE ANCHOR FRACTURING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11251565 ↗
Other Fastener, Fixation, Nondegradable, Soft Tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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