S-ROM 2576-00-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295145271), received between Sep 11, 2018 and Sep 16, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796499 ↗
• MalfunctionSep 13, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT UPON INSPECTION THE FOLLOWING PARTS WERE FOUND. SROM BOX OSTEOTOME - GOUGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216980 ↗
• MalfunctionOct 4, 2023Material Deformation; Material Deformation

  END OF BOX OSTEOTOME IS WARPED/DAMAGED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873412 ↗
• MalfunctionDec 6, 2022Failure to Cut; Scratched Material; Failure to Cut; Scratched Material

  IT WAS REPORTED THAT BOX OSTEOTOME IS DULL AND JAGGED. SUCTION CUP DOESN¿T STICK. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924308 ↗
• MalfunctionAug 25, 2020Break; Naturally Worn; Break; Naturally Worn

  BROKEN ATTUNE SHIM AND IMPACTOR. BROKEN AND WORN SROM OSTEOTOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448486 ↗
• MalfunctionMar 4, 2019Dull, Blunt; Material Twisted/Bent; Naturally Worn; Dull, Blunt; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE BOX OSTEOTOME FROM SROM STARTER INSTRUMENTS TRAY WAS WORN AND DULLED PAST THE POINT OF BEING USEFUL. SURGICAL DELAY OF 1 MINUTE.

  Patient problems: No Code Available

  MAUDE report 8386688 ↗
• MalfunctionDec 26, 2018Dull, Blunt; Dull, Blunt

  EXCESSIVE WEAR AND LACK OF SHARPNESS OF SOME S-ROM LOANER SET ESPECIALLY WHEN SOILED WITH BLOOD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196814 ↗
• MalfunctionSep 11, 2018Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  IT WAS REPORTED THAT THE SROM OSTEOTOME IS DAMAGED FROM HARD BONE. THE SMOOTH CUTTING SURFACE IS NO LONGER SMOOTH ENOUGH TO USE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7863693 ↗