GLOBAL 2235-02-000Recalls & reported problems

Depuy Orthopaedics, Inc. · GLOBAL ORIGINAL BROACH HANDLE · Class 1

All models of GLOBAL (20)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295105367), received between Aug 8, 2018 and Aug 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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.

Most reported problems

Device problems

Device-Device Incompatibility1
Naturally Worn1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 8, 2018Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
INSTRUMENT ISSUE DURING: REVISION (L) HEMI ARTHROPLASTY TO REVERSE. INTERNAL THREAD AT THE TOP OF THE INSTRUMENT, THAT THE SLAP HAMMER ATTACHES TO, IS DAMAGED BEYOND REPAIR. WE ARE UNABLE TO CONNECT THE SLAP HAMMER AT ALL. THE SIDE SCREW IS ALSO THREADED & WE REQUIRED LOCKING PLIERS TO TURN IT SO WE COULD LOCK THE HANDLE ONTO THE STEM. ACTION TAKEN TO MANAGE ISSUE: ALTERNATIVE HOSPITAL INSTRUMENTS USED TO EXTRACT THE HUMERAL STEM. NO DELAY TO PROCEDURE. NO AE TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7762383 ↗

Device details

UDI-DI	`10603295105367`
Brand	GLOBAL
Model	2235-02-000
Catalog no.	223502000
Company	Depuy Orthopaedics, Inc.
Product code	HTQ · BROACH
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	Oct 25, 2018

Device type (GMDN): Surgical instrument handle, non-torque-limiting

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Other BROACH devices

NA 2598-07-550
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SUMMIT 2570-00-000
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269 reports
NA 952212500F
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245 reports
ACTIS 2010-01-050
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235 reports
CORAIL 9522-11-500
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210 reports
ACTIS 2010-01-060
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186 reports
ACTIS 2010-01-040
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172 reports
ACTIS 2010-01-070
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162 reports

All BROACH 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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