PINNACLE 2218-10-056Recalls & reported problems

Depuy (Ireland) · PINNACLE CERAMIC LINER INSERTER GRIPPER 56mm · 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 10603295457237), received between Sep 1, 2021 and Sep 1, 2021 — 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.

MalfunctionSep 1, 2021Break; Break
THIS ACTUALLY BROKE AND THEY THREW IT AWAY! SO I DON¿T HAVE THE LOT NUMBER, IT ISN¿T AVAILABLE FOR RETURN, IT HAPPENED DURING THE CASE, THERE WAS NO DELAY TO THE CASE AS THEY OPENED UP A SECOND TRAY, IT WAS REPORTED ON SATURDAY 14TH AUGUST, APPARENTLY ONE OF THE ATTACHMENTS SNAPPED OFF WHILST TRYING TO ASSEMBLE THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12410999 ↗

Device details

UDI-DI	`10603295457237`
Brand	PINNACLE
Model	2218-10-056
Catalog no.	221810056
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 2218-10-058
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.

How reports and recalls are matched · Editorial policy · Report an error on this page