REUNION 5901-0028Recalls & reported problems

Stryker GmbH · Peg,Keel Drill · Class 1

All models of REUNION (113)

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 07613327099225), received between Jun 29, 2020 and Jun 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Fracture1

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.

MalfunctionJun 29, 2020Fracture; Fracture
AS REPORTED: "WHILE DRILLING THE INFERIOR/POSTERIOR HOLE, FOR PREPARATION OF A PEGGED GLENOID IMPLANT DURING A REUNION TSA PROCEDURE, THE TIP OF THE PEG/KEEL DRILL (5901-0028) GOT BOUND INTO THE DRILL HOLE OF THE PEGGED DRILL GUIDE (5901-1026L) WHICH IN TURN RESULTED IN THE TIP OF THE PEG/KEEL DRILL (5901-0028) TO BREAK OFF. THE SECOND PEG/KEEL DRILL (5901-0028) THAT IS PROVIDED IN THE INSTRUMENT SET WAS USED WITHOUT DIFFICULTIES."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10209178 ↗

Device details

UDI-DI	`07613327099225`
Brand	REUNION
Model	5901-0028
Company	Stryker GmbH
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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	Apr 14, 2025

Device type (GMDN): Fluted surgical drill bit, reusable

A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

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All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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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