NA SM-4011MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817438027673), received between May 27, 2022 and May 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2022Break; Entrapment of Device

  IT WAS REPORTED THAT DURING PODIATRIC SURGERY, A SMALL PORTION OF BLADE TEETH BROKE OFF INTO THE 3RD CURNIFORM WHILE THE SURGEON WAS MAKING CUTS WITH THE ZERO DEGREE ADDUCTOPLASTY CUT GUIDE. THE BROKEN PORTION COULD NOT BE REMOVED FROM PATIENT. SURGEON INDICATED THAT EITHER THE BLADE MADE CONTACT WITH A SHORT PIN FIXATION AND BROKE OFF OR THE BLADE BECAME TOO HOT AND BROKE OFF. A BACKUP DEVICE WAS AVAILABLE FOR USE AND THE SURGERY WAS COMPLETED WITHOUT ADVERSE DELAY. THE BREAKAGE DID NOT PREVENT SUCCESSFUL COMPLETION OF SURGERY. NO IRREVERSIBLE IMPAIRMENT OR DAMAGE TO PATIENT. DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION COULD NOT BE COMPLETED REGARDING CAUSE OF BREAKAGE AND NO CONCLUSION DRAWN. INSPECTION OF QUALITY DOCUMENTS DEMONSTRATE NO DEVIATION OF MATERIAL CERTIFICATES OR DEVICE SPECIFICATIONS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14526681 ↗