Arthrex® AR-8920PRecalls & reported problems

Arthrex, Inc. · GDWIRE,T-ROPE SYNDESMOSIS REPR KIT · Class 1

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 10888867049021), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Physical Resistance/Sticking1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionJul 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A SYNDESMOSIS SURGERY THE DRILL GOT STUCK INSIDE THE TIGHTROPE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE CMACKENBACH 3-JUL-2025 FURTHER INFORMATION WAS RECEIVED THAT INITIAL PROVIDED INFORMATION WAS INCORRECT. APPARENTLY, THE GUIDEWIRE FOR TIGHTROPE AR-8920P GOT STUCK ON THE DRILL BIT AR-8925DC-RU. IT WAS THEN IMPOSSIBLE TO SEPARATE TE TWO PARTS.
Patient problems: Insufficient Information
MAUDE report 22542164 ↗

Device details

UDI-DI	`10888867049021`
Brand	Arthrex®
Model	AR-8920P
Company	Arthrex, Inc.
Product code	MDM · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 13, 2021

Device type (GMDN): Fluted surgical drill bit, single-use

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 mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.