MOSAICPLASTY 7209234Recalls & reported problems
Smith & Nephew, Inc. · MOSAICPLASTY DISPOSABLE HARVESTING SET, 3.5, INCLUDES DISPOSABLE CHISEL, TAMP, AND DRILL BIT BLUE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010473127), received between Jun 30, 2022 and Apr 18, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2024Break; Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE CUFF STITCH 180 BROKE BETWEEN THE SOFT TISSUE WHEN ATTEMPTING TO PIERCE THE TISSUE. PIECE WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19135790 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE CUFF STITCH WAS BROKEN WHEN THE WIRE WAS PASSED THROUGH THE TENDON. SURGERY WAS COMPLETED WITH THE SAME REPORTED DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080367 ↗MalfunctionOct 10, 2023Break; Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE CUFF STITCH BROKE AFTER PUTTING TOO MUCH FORCE ON THE CLAMP. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17906924 ↗MalfunctionOct 2, 2023Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE CUFF STITCH BROKE IN THE TENDON PASSAGE. THE ENTIRE TIP WAS REMOVED WITH THE HELP OF GRASPER. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17855243 ↗InjuryJun 30, 2022Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY LAB/DEMO PROCEDURE, THE CUFF STITCH BROKE INTO PIECES WHEN PASSING THE TENDON. IT BROKE INSIDE THE PATIENT BUT ALL THE BROKEN PIECES WERE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14881946 ↗
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- MITEK 242018Medos International Sàrl · Arthroscope731 reports
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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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