SPECIALIST 96-6327Recalls & reported problems

Depuy (Ireland) · SPECIALIST 2 SLOTTED TIBIAL CUTTING BLOCK 3 DEGREE RIGHT · Class 1

All models of SPECIALIST (80)

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

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295247890), received between Feb 7, 2019 and Apr 30, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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

Material Deformation4
Mechanical Jam3
Adverse Event Without Identified Device or Use Problem1
Device-Device Incompatibility1

Patient problems

No Consequences Or Impact To Patient3
Loss of Range of Motion1
Muscular Rigidity1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS A STIFF, WITH LIMITED MOTION, RIGHT TOTAL KNEE. IT IS UNKNOWN WHEN THE KNEE WAS DONE. THE SURGEON DID A DEBRIDEMENT AND IMPLANTED A THINNER TIBIAL INSERT. ALL OTHER COMPONENTS ARE WELL FIXED AND RETAINED. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Loss of Range of Motion; Muscular Rigidity
MAUDE report 21936401 ↗
MalfunctionApr 30, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936384 ↗
MalfunctionFeb 7, 2019Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam
IT WAS REPORTED THAT THE SAW BLADE IS GETTING STUCK IN THE GUIDES. REPORTEDLY NO SURGICAL DELAYS HAPPEN. THE DEVICE WAS NOT BROKEN INTO TWO (2) PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317783 ↗
MalfunctionFeb 7, 2019Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam
IT WAS REPORTED THAT THE SAW BLADE IS GETTING STUCK IN THE GUIDES. REPORTEDLY NO SURGICAL DELAYS HAPPEN. THE DEVICE WAS NOT BROKEN INTO TWO (2) PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317761 ↗
MalfunctionFeb 7, 2019Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam
IT WAS REPORTED THAT THE SAW BLADE IS GETTING STUCK IN THE GUIDES. REPORTEDLY NO SURGICAL DELAYS HAPPEN. THE DEVICE WAS NOT BROKEN INTO TWO (2) PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317738 ↗

Device details

UDI-DI	`10603295247890`
Brand	SPECIALIST
Model	96-6327
Catalog no.	966327
Company	Depuy (Ireland)
Product code	HTZ · INSTRUMENT, CUTTING, ORTHOPEDIC
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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All INSTRUMENT, CUTTING, ORTHOPEDIC devices →

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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