S-ROM 53-4400Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295171973), received between Sep 13, 2017 and Apr 2, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING HIP SURGERY. IT BENT IN HALF WHEN USING IT FOR EXTRACTION. THERE WAS NOTHING LEFT IN THE PATIENT. IT DID NOT CAUSE ANY DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766557 ↗
• MalfunctionOct 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ARON LOOP WAS NOTICEABLE BENT/WARPED/SPRUNG UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381848 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENT BROKE DURING HIP SURGERY. PART OF IT HAS SNAPPED; NOTHING WAS LEFT INSIDE THE PATIENT AND THERE WERE NO DELAYS TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923245 ↗
• MalfunctionOct 30, 2023Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  IT WAS REPORTED THAT THE THREADED LOOP ATTACHMENT IS STRIPPED AND KEPT COMING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036104 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING HIP SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597248 ↗
• 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 17444247 ↗
• MalfunctionJul 28, 2023Crack; Crack

  IT WAS REPORTED THAT THE HORSESHOE LOOKING PIECE OF THE SLAP HAMMER GOT A CRACK THROUGH IT. IT DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413343 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT THE THREADED PORTION OF THE LOOP EXTRACTOR WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165151 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT DEVICE IS BROKEN, NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154966 ↗
• MalfunctionMar 29, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE EXTRACTED FEMORAL STEM MENTIONED IS NOT A DEPUY PRODUCT. LOT NUMBER WAS ILLEGIBLE IN THE ADAPTERS. IT WAS THE THREADED PART THAT BROKE FROM THE BODY. THERE WERE NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639947 ↗
• MalfunctionFeb 27, 2023Crack; Crack

  DURING SURGERY YESTERDAY, (B)(6) 2023, THE FOLLOWING SROM INSTRUMENTS WERE DAMAGED DURING THE PROCEDURE WHEN TRYING TO REMOVE THE SIZE 2 MILLER WHICH GOT STUCK IN THE PATIENT¿S FEMUR.

  Patient problems: Insufficient Information

  MAUDE report 16444815 ↗
• MalfunctionOct 6, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE SROM LOOP EXTRACTOR WAS CROSS-THREADED IN THE SLAP HAMMER AND WOULD NOT COME APART AT THE END OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552292 ↗
• MalfunctionJul 5, 2022Break; Break

  DURING REMOVAL OF A STEM THE LOOP BROKE. NO FRAGMENTS. CLEAN BREAK AT TIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914936 ↗
• MalfunctionMar 15, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE SROM LOOP EXTRACTOR FOR SLAP HAMMER BROKE DURING STEM EXPLANT. ALL PIECES WERE RETRIEVED AND THERE WAS NO DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770052 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT THE SROM LOOP EXTRACTOR SPLIT IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852447 ↗
• 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 12605290 ↗
• MalfunctionSep 23, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LOOPED EXTRACTOR BROKE WHILE TRYING TO REMOVE STEM. THREADS FROM EXTRACTOR LOOP STUCK IN SLAP HAMMER HANDLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519106 ↗
• MalfunctionApr 16, 2021Break; Break

  CONSIGNMENT SROM EXTRACTOR STEM LOOP BROKE WHILE USING IT TO EXTRACT A COMPETITOR STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678354 ↗
• MalfunctionOct 13, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE EVENT HAPPENED DURING THE OPERATION. NO PARTS WERE LEFT BEHIND ON THE STERILE FIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10672971 ↗
• 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 10449653 ↗
• MalfunctionJun 10, 2020Crack; Crack

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE BASE OF THE HOOK WHERE IT ATTACHES TO THE SHAFT WAS CRACKED, BUT STILL IN ONE PIECE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138450 ↗
• MalfunctionJan 17, 2020Break; Break

  THE INSTRUMENT HAD BROKEN. THE REPS THAT WERE COVERING WERE UNABLE TO PROVIDE ME WITH ADDITIONAL INFORMATION (DAY IN WHICH THEY BROKE, DURATION OF SURGERY, PATIENT INFORMATION, ETC.).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601961 ↗
• MalfunctionDec 16, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT NOTHING WAS DELAYED. THE SLEEVE EXTRACTOR WAS NOT ABLE TO BE REMOVED AND THE LOOP BROKE AT THE LOOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475830 ↗
• MalfunctionAug 22, 2019Break; Break

  IT WAS REPORTED THAT THE SLAP HAMMER HOOK BROKE OPEN DURING NORMAL USE. NO PIECES BROKE OFF OF INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920442 ↗
• MalfunctionAug 7, 2019Crack; Crack

  IT WAS REPORTED THAT THE LOOP CRACKED / SEPARATED WHEN TRYING TO BACK SLAP A STEM.

  Patient problems: Not Applicable

  MAUDE report 8871080 ↗