Quattro® X Suture Anchor CM-9255BGRecalls & reported problems
Cayenne Medical, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868270949), received between May 24, 2021 and Aug 9, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2021Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT SHAFT BROKE WHEN SURGEON WAS IMPACTING DEVICE AS PER SURGICAL TECHNIQUE. METAL SHAFT COULD NOT BE REMOVED FROM PATIENT HUMERAL HEAD. FRACTURE IMPLANT LEFT IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 12294440 ↗MalfunctionMay 24, 2021Fracture; Fracture
IT WAS REPORTED DURING AN INITIAL ROTATOR CUFF RECONSTRUCTION, AFTER PUNCTURING THE BONE, THE ANCHOR WAS INSERTED INTO THE TISSUE AND THEN GENTLY TAPPED ON THE ANCHOR INSERTER. THEN THE OPERATOR STARTED SCREWING THE ANCHOR, BUT THE ANCHOR DID NOT SCREWED IN THAT IS WHY THE OPERATOR PULLED OUT THE INSERTER FEW TIMES AND THE ANCHOR WAS BROKE. ALL COMPONENTS WERE REMOVED FROM THE PATIENT. ANOTHER ANCHOR WITH THE SAME LOT WAS USED WITHOUT FURTHER COMPLICATIONS. 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 11869540 ↗
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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