SIGMA HIGH PERFORMANCE 9505-02-060Recalls & reported problems

Depuy (Ireland) · SIGMA HIGH PERFORMANCE FBT DRILL TOWER · Class 1

All models of SIGMA HIGH PERFORMANCE (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295227762), received between Sep 19, 2022 and Jun 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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

Device problems

Material Deformation2
Device-Device Incompatibility1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 5, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT ON (B)(6) 2023, THE TOWER IS BENT. THIS REPORT IS FOR A SIGMA HP FBT DRILL TOWER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17058300 ↗
MalfunctionSep 19, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE TINES ARE BENT INWARD CAUSING REAMER TO NOT FIT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445262 ↗

Device details

UDI-DI	`10603295227762`
Brand	SIGMA HIGH PERFORMANCE
Model	9505-02-060
Catalog no.	950502060
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): Surgical drill guide, reusable

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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