S-ROM NOILES 63-3305ARecalls & reported problems

Depuy (Ireland) · S-ROM NOILES BOX CUT GUIDE AUGMENT SPACER 5mm · Class 1

All models of S-ROM NOILES (25)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295180029), received between Jan 16, 2024 and Sep 18, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break6
Scratched Material3

Patient problems

No Clinical Signs, Symptoms or Conditions4
Insufficient Information2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 18, 2025Break; Break
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING SURGERY. THE 5MM SROM HINGE BLUE BUSHING WAS CHIPPING OF PIECES. NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084908 ↗
MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED THAT THE AUGMENTS WERE GRABBED WITH INSTRUMENTS AND WERE FALLING APART. PARTS OF THE PLASTIC WERE SHEDDING OFF.
Patient problems: Insufficient Information
MAUDE report 20281140 ↗
MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED THAT THE AUGMENTS WERE GRABBED WITH INSTRUMENTS AND WERE FALLING APART. PARTS OF THE PLASTIC WERE SHEDDING OFF.
Patient problems: Insufficient Information
MAUDE report 20281136 ↗
MalfunctionMar 27, 2024Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THERE ARE GOUGE MARKS ALL AROUND ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18986919 ↗
MalfunctionJan 16, 2024Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE FEMORAL TRIAL IS CUT/GOUGED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18519442 ↗
MalfunctionJan 16, 2024Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE FEMORAL TRIAL IS CUT/GOUGED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18518586 ↗

Device details

UDI-DI	`10603295180029`
Brand	S-ROM NOILES
Model	63-3305A
Catalog no.	633305A
Company	Depuy (Ireland)
Product code	HWT · TEMPLATE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 28, 2026

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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