S-ROM 53-1500Recalls & reported problems
Depuy (Ireland) · S-ROM PIN PUNCH · Class 1
All models of S-ROM (185)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy S-ROM pin punch is a surgical instrument used to prepare bone. The 24 reports describe the punch or its tip bending, deforming, or breaking, including a handle separating from the shaft; reports mention no patient impact. There were 24 malfunctions, no deaths, and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295171591), received between Oct 19, 2017 and May 28, 2024 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (11 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent11
- Material Deformation10
- Break3
- Bent2
- Illegible Information2
- Naturally Worn2
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient14
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
- No Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF. THE PENCIL TIP WAS BENT.
Patient problems: Insufficient Information
MAUDE report 19404130 ↗MalfunctionFeb 13, 2024Break; Material Deformation; Break; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED: TIP WAS BENT. NO SURGICAL DELAY. PATIENT WAS FINE. LOT NUMBERS UNKNOWN. THE TIP DID NOT BREAK INTO TWO PIECES BUT WAS BENT 90 DEGREES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18694118 ↗MalfunctionJan 29, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT INSTRUMENT BENT IN WASHER. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18602889 ↗MalfunctionFeb 9, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PIN PUNCH WAS BENT DURING USE. NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16335456 ↗MalfunctionDec 1, 2022Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
UPON INSPECTION IN MDR AFTER REPROCESSING DEVICE #: 531500 AND DEVICE #: 540030 WERE DISCOVERED DAMAGED/BROKEN. PART #: 531500 IS BENT AND DAMAGED. PART #: 540030 IS BROKEN - T-HANDLE PORTION HAS SEPARATED FROM THE SHAFT OF THE DEVICE. THESE ITEMS ARE FROM LOANER SETS FROM DEPUY SYNTHES CANADA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15895156 ↗MalfunctionJul 5, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE S-ROM*PIN PUNCH IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14916551 ↗MalfunctionJul 5, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE ¿S-ROM*PIN PUNCH IS BENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14915966 ↗MalfunctionMar 24, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE VERSION PIN GOT BENT AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13890755 ↗MalfunctionMar 2, 2021Break; Break
IT WAS REPORTED THAT THE PIN PUNCH BROKE. THE SURGEON USED IT TO REMOVE THE TRIAL STEM. ALL PIECES WERE RECOVERED FROM THE PATIENT. EVENT DID NOT DELAY THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11398463 ↗MalfunctionMay 11, 2020Material Twisted/Bent; Scratched Material; Illegible Information; Material Twisted/Bent; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10043319 ↗MalfunctionMar 31, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT SROM INSTRUMENTS ARE DIFFICULT OR IMPOSSIBLE TO READ THE SIZING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9906859 ↗MalfunctionMar 25, 2020Break; Break
BROKEN ATTUNE SHIM, SROM PIN PUNCH AND BONE SCREW ANGLED DRIVER REPORTED BY CSSD STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9879548 ↗MalfunctionFeb 24, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
PIN PUNCH WAS USED TO ADJUST THE VERSION OF THE STEM AND IT BENT. OUTCOME OF THE PROCEDURE NOT AFFECTED BY THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9746449 ↗MalfunctionJan 7, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
PIN PUNCH BECAME BENT DURING SURGERY, RESULTED IN NO DELAY. ITEM DID NOT BREAK INTO 2 OR MORE PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9558316 ↗MalfunctionOct 22, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PIN PUNCH IS BENT AND NEEDS REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9219204 ↗MalfunctionSep 30, 2019Material Twisted/Bent; Material Twisted/Bent
THE TOMMY BAR TO CONTROL VERSION BENT DURING SURGERY WHEN THE SURGEON WAS REMOVING THE TRIAL STEM. PLEASE SHIP P1 TO (B)(6) TO BE PUT BACK IN OFFICE SET FOR SURGERY ON (B)(6) 2019. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9135103 ↗MalfunctionMay 20, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE S-ROM*PIN PUNCH WAS BENT DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8625561 ↗MalfunctionApr 4, 2019Material Twisted/Bent; Material Twisted/Bent
PART DISCOVERED BENT IN CENTRAL STERILE PROCESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8483762 ↗MalfunctionNov 16, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PIN PUNCH TIP IS BENT. NO SURGICAL DELAY
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8080776 ↗MalfunctionAug 22, 2018Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN OUT AND BENT AND NEEDS TO BE REPLACED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7805542 ↗MalfunctionAug 21, 2018Material Twisted/Bent; Material Twisted/Bent
COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE PIN PUNCH WAS BENT AND WAS DISCOVERED WHEN RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7800774 ↗MalfunctionJul 13, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE S-ROM*PIN PUNCH WAS BENT WHEN IT WAS RETURNED FROM STERILE PROCESSING. THE INSTRUMENT IS IN ONE PIECE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7684935 ↗MalfunctionApr 11, 2018Bent; Bent
IT WAS REPORTED THAT IDENTIFYING MARKS FOUND TO BE DAMAGED AND THE PIN WAS BENT IN POST CLEANING INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7421529 ↗MalfunctionOct 19, 2017Bent; Bent
IT WAS REPORTED THAT THE VERSION GUIDE WAS BENT WHILE TRYING TO REMOVE THE STEM.
Patient problems: No Information
MAUDE report 6961160 ↗
Other PUNCH, SURGICAL devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- SIGMA LCS 9505-02-018Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall10 reports
- DJO SURGICAL 801-05-040Encore Medical, L.P. · PUNCH, SURGICAL1 recall7 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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