Quattro® Link SP Knotless Anchor CM-9145SPRecalls & reported problems
Cayenne Medical, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cayenne Medical Quattro Link SP knotless anchor is a soft-tissue fixation implant used to attach tissue to bone during surgery. The 48 reports mostly describe the anchor fracturing or snapping during placement, sometimes into several pieces, and bent or deformed inserter tips; fragments were recovered in some cases. No deaths were reported, and 6 reports involved injuries. No recalls name 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
- 48
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00887868270208), received between Feb 4, 2021 and Aug 31, 2026 — classified as 6 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Fracture” (41 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
- Fracture41
- Material Twisted/Bent3
- Detachment of Device or Device Component2
- Break1
- Labelling, Instructions for Use or Training Problem1
- Material Deformation1
- Migration or Expulsion of Device1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Failure of Implant11
- Foreign Body In Patient8
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519695 ↗MalfunctionMay 29, 2026Material Twisted/Bent
IT WAS REPORTED THAT AN ANCHOR WAS BENT. RETURNED DEVICE AND INVESTIGATION COMPLETION NOTED THAT THE ANCHOR IS FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333750 ↗MalfunctionFeb 27, 2026Material Deformation
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE DEVICE INSERTER DEFORMED WHEN THE SURGEON ATTEMPTED TO IMPLANT AN ANCHOR, PREVENTING ANCHOR IMPLANTATION. THERE WERE NO KNOWN 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 24471152 ↗MalfunctionDec 15, 2025Fracture; Labelling, Instructions for Use or Training Problem; Fracture; Labelling, Instructions for Use or Training Problem
IT WAS REPORTED THAT DURING SURGERY, THE ANCHOR BROKE WHEN IT WAS DRIVEN INTO THE BONE. A SECOND ANCHOR WAS USED IN THE SAME LOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802619 ↗MalfunctionDec 1, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT, DURING PLACEMENT OF AN ANCHOR IN THE HUMERAL HEAD, THE IMPLANT SCREW FRACTURED WHEN THE ANCHOR WAS IMPACTED DURING THE FIRST STAGE OF THE PROCEDURE. THE SCREW BROKE INTO FOUR PIECES, AND WHEN THE ANCILLARY DEVICE WAS REMOVED, THE IMPLANT SUPPORT RODS WERE OBSERVED TO BE BENT AT APPROXIMATELY A 90° ANGLE. ALL FRAGMENTS WERE RECOVERED INTRA-OPERATIVELY, AND THE EVENT RESULTED IN PROLONGED OPERATING TIME. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680931 ↗MalfunctionApr 23, 2025Fracture; Fracture
IT WAS REPORTED DURING ROTATOR CUFF REPAIR SURGERY, DURING ANCHOR DEPLOYMENT, THE ANCHOR FRACTURED. 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 21890975 ↗MalfunctionJan 22, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21209538 ↗MalfunctionNov 20, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20733580 ↗MalfunctionOct 30, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20566882 ↗MalfunctionOct 30, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20566862 ↗InjuryAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED APPROXIMATELY ONE (1) MONTH POST OP THAT THE SURGEON NOTICED ON X-RAY THAT PART OF THE IMPLANT HAD DISASSEMBLED FROM ITSELF. THE PATIENT DID NOT REPORT ANY CLINICAL SYMPTOMS OR CLINICAL SIGNS AND THERE IS NO PLAN FOR A REVISION SURGERY TO REMOVE THE FOREIGN BODY FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 20001694 ↗MalfunctionAug 13, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER THE SURGEON HAD IMPLANTED THE ANCHOR, THEY REMOVED THE ANCHOR AND FOUND THAT THE IMPLANT FRACTURED AT THE CLEAT. THERE WAS NO REPORT OF HARM OR FOREIGN BODY RETAINED BY THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19972919 ↗MalfunctionJul 17, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING RIGHT SHOULDER SURGERY. SURGEON WAS USING A QUATTRO LINK SP KNOTLESS ANCHOR AND THE TIP OF THE DEVICE BROKE OFF IN PATIENT. SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECES OF THE DEVICE AND THE SURGERY WAS COMPLETED. NO HARM TO PATIENT WAS NOTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 19762093 ↗MalfunctionJun 18, 2024Fracture; Fracture
IT WAS REPORTED THAT THE ANCHOR FRACTURED DURING THE SURGERY, WHILE SURGEON WAS PUNCHING THE ANCHOR AT SITE OF SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 19558722 ↗MalfunctionJun 6, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE TYVEK OF STERILE PACKAGE IS PUNCTURED WHEN THE NURSE OPENED THE OUTER PACKAGE. 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 19476558 ↗InjuryApr 25, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 19182487 ↗MalfunctionApr 2, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, WHEN HAMMERING IN THE DEVICE INTO THE BONE, THE TIP FRACTURED OFF. THE PROPER SURGICAL TECHNIQUE WAS FOLLOWED. THE MATERIAL WAS COMPLETELY REMOVED FROM THE PATIENT'S BONE. THE SURGEON USED A NEW DEVICE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER COMPLICATIONS.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 19018622 ↗MalfunctionMar 25, 2024Fracture; Fracture
ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 18970834 ↗MalfunctionDec 21, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 18371966 ↗MalfunctionNov 13, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL TISSUE REPAIR PROCEDURE, THE ANCHOR FRACTURED DURING IMPLANTATION. ALL PARTS WERE RECOVERED AND THERE WERE NO REPORTED ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18120648 ↗MalfunctionAug 9, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17489249 ↗MalfunctionAug 1, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17435309 ↗MalfunctionJun 12, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108241 ↗MalfunctionMay 18, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE ANCHOR BROKE. 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 16953765 ↗MalfunctionMay 8, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16891274 ↗
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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