S-ROM 53-1206Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295171560), received between Jul 12, 2018 and Sep 5, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED. A. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN, CROSS THREADED OR ANY DEVICE INTERACTION ISSUES? -BROKE IN TWO PIECES B. WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? -ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684473 ↗
• MalfunctionAug 2, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICES BROKE AT THREADS. ALL PIECES WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444250 ↗
• MalfunctionJan 26, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE PIN IN T HANDLE OF MILLER FRAME CAME LOOSE. LOOP EXTRACTOR WON'T SCREW INTO SLAP HAMMER HANDLE BECAUSE IT WAS STRIPPED. NO SURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247208 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT THE SLAP HAMMER BROKE OFF UPON EXTRACTION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595078 ↗
• MalfunctionFeb 22, 2022Break; Break

  THE THREADS ON THREADED ADAPTER BROKE OFF IN SLAP HAMMER DURING USE. NO PATIENT HARM OR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579906 ↗
• MalfunctionFeb 7, 2022Naturally Worn; Naturally Worn

  THREADS ON THE INSTRUMENT ARE STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477143 ↗
• MalfunctionOct 11, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE HOOK AND THREADED SHAFT OF THE SROM EXTRACTION ROD IS BELIEVED TO BE CROSS-THREADED AND WILL NOT COME APART. THIS AFFECTS ALL 4 PIECES ON THE SLAP HAMMER EXTRACTION TOOL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605293 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT THE SROM SLAP HAMMER WILL NO LONGER ENGAGE WITH LOOPED CONNECTION, IT APPEARS TO HAVE A BROKEN PIECE OF METAL INSIDE THE THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726897 ↗
• MalfunctionAug 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  S-ROM EXTRACTOR HAS A SPLIT ON THE HANDLE. CANNOT DISMANTLE THE HOOK FROM THE EXTRACTOR HANDLE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10449626 ↗
• MalfunctionMar 27, 2019Break; Material Deformation; Material Twisted/Bent; Naturally Worn; Break; Material Deformation; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE FEMALE THREADING STRIPPED. DAMAGED MALE THREADING DURING USE. IT WAS INDICATED BY THE SALES REP THAT NO PIECES CAME OFF THE THREADING AND NO PIECES WERE IN THE PATIENT. THREADS ARE SHEARING OFF. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455298 ↗
• MalfunctionOct 12, 2018Break; Break

  IT WAS REPORTED THAT THE S-ROM SLAP HAMMER BROKE WHILE EXTRACTING THE STEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960843 ↗
• MalfunctionJul 12, 2018Break; Break

  THE SHAFT IS DISSOCIATED OF THE HANDLE. (B)(4) FOR REPLACEMENT. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7682310 ↗