PINNACLE 2218-10-058Recalls & reported problems

Depuy (Ireland) · PINNACLE CERAMIC LINER INSERTER GRIPPER 58mm · Class 1

All models of PINNACLE (198)

Data updated Oct 16, 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 10603295457244), received between Mar 6, 2023 and Mar 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMar 6, 2023Break; Break
IT WAS REPORTED THAT SURGEON WENT TO INSERT THE CERAMIC LINER WITH THE CERAMIC INSERTER AND WHEN HE REMOVED THE INSTRUMENT AN ARM OFF OF THE YELLOW INSERTER BROKE OFF. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16491542 ↗

Device details

UDI-DI	`10603295457244`
Brand	PINNACLE
Model	2218-10-058
Catalog no.	221810058
Company	Depuy (Ireland)
Product code	HXO · PUSHER, SOCKET
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	Sep 11, 2024

Device type (GMDN): Orthopaedic inorganic implant inserter/extractor, reusable

A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Other PUSHER, SOCKET devices

NA 2299-90-025
Depuy Orthopaedics, Inc. · PUSHER, SOCKET
9 reports
NA 2299-90-030
Depuy Orthopaedics, Inc. · PUSHER, SOCKET
5 reports
PINNACLE 2218-10-054
Depuy (Ireland) · PUSHER, SOCKET
2 reports
FIREBIRD SFS 51-7111
Orthofix US LLC · PUSHER, SOCKET
1 report
PINNACLE 2218-10-056
Depuy (Ireland) · PUSHER, SOCKET
1 report

All PUSHER, SOCKET 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 13, 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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