Quattro Link Knotless AnchorRecalls & reported problems across all models
Cayenne Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56
- Deaths reported
- 1
- Injuries reported
- 12
- Recalls
- 0
We found 3 models of Quattro Link Knotless Anchor by Cayenne Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between May 4, 2020 and Feb 17, 2026 — classified as 1 death, 12 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Fracture” (47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Quattro Link Knotless Anchor problems
Device problems
- Fracture47
- Material Twisted/Bent2
- Separation Failure2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Foreign Body In Patient6
- Device Embedded In Tissue or Plaque4
- No Code Available4
- Failure of Implant3
- No Consequences Or Impact To Patient2
- Pain1
Quattro Link Knotless Anchor models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quattro® Link Knotless Anchor CM-9145Fastener, Fixation, Nondegradable, Soft Tissue1 death30 reports
- Quattro® Link Knotless Anchor CM-9129Fastener, Fixation, Nondegradable, Soft Tissue13 reports
- Quattro® Link Knotless Anchor CM-9155Fastener, Fixation, Nondegradable, Soft Tissue13 reports
Recent Quattro Link Knotless Anchor adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗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 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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