NA 202953Recalls & reported problems

Depuy Spine, LLC · SPINAL INSTRUMENT STRAIGHT CHISEL, LARGE 12.70mm · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034000893), received between Feb 27, 2019 and Feb 27, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Material Fragmentation4

Patient problems

No Consequences Or Impact To Patient4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 27, 2019Material Fragmentation; Material Fragmentation
IT WAS REPORTED BAD INSTRUMENTS SHIPPED. CHIPPED BLADES. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8375337 ↗
MalfunctionFeb 27, 2019Material Fragmentation; Material Fragmentation
IT WAS REPORTED BAD INSTRUMENTS SHIPPED. CHIPPED BLADES. DID THE EVENT OCCUR DURING STERILE PROCESSING? --> UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? --> UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8375007 ↗
MalfunctionFeb 27, 2019Material Fragmentation; Material Fragmentation
IT WAS REPORTED BAD INSTRUMENTS SHIPPED. CHIPPED BLADES. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN. DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8374854 ↗
MalfunctionFeb 27, 2019Material Fragmentation; Material Fragmentation
IT WAS REPORTED BAD INSTRUMENTS SHIPPED. CHIPPED BLADES. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN. DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8374103 ↗

Device details

UDI-DI	`10705034000893`
Brand	NA
Model	202953
Company	Depuy Spine, LLC
Product code	FZO · CHISEL, SURGICAL, MANUAL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Orthopaedic chisel

A hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

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All CHISEL, SURGICAL, MANUAL 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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