NA STR4135-089-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551030755), received between Dec 9, 2019 and Jan 9, 2020 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A (B)(6), FEMALE PATIENT UNDERWENT A TOTAL KNEE REVISION WITH A REPROCESSED SAW BLADE SAGITTAL DUAL CUT AND THE RECIPROCATING SAW BLADE BROKE DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569527 ↗
• MalfunctionDec 9, 2019Break

  RECIPROCATING SAW BLADE BROKE INTRA-OP DURING A TOTAL KNEE REVISION PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9436980 ↗