Arthrex® AR-1510HRecalls & reported problems

Arthrex, Inc. · ACL GUIDE FRAME HANDLE ASS'Y · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867018372), received between Sep 9, 2024 and Sep 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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/Sticking2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A SHOULDER PROTHESIS SURGERY THE 3MM DRILL WAS PASSED THROUGH THE DRILL SLEEVE AND THE DEVICES THEN COLD-WELDED. THIS RESULTED IN ABRASION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE KPILZ 30-AUG-2024: THE ABRASION DID NOT ENTER THE PATIENT. UPDATE KPILZ 16-SEP-2024: THE HANDLE IS WORN AT THE INTERFACE TO THE REDUCTION SLEEVE. THE CUSTOMER PROVIDED THE INFORMATION ON THE (B)(6) 2024 THAT THE HANDLE WAS USED DURING THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20248952 ↗
MalfunctionSep 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A SHOULDER PROTHESIS SURGERY THE 3MM DRILL WAS PASSED THROUGH THE DRILL SLEEVE AND THE DEVICES THEN COLD-WELDED. THIS RESULTED IN ABRASION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 30-AUG-2024: THE ABRASION DID NOT ENTER THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20169296 ↗

Device details

UDI-DI	`00888867018372`
Brand	Arthrex®
Model	AR-1510H
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	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 1, 2022

Device type (GMDN): Surgical drill guide, reusable

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices

Arthrex® AR-13995N
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
430 reports
Arthrex® AR-12990N
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
197 reports
Arthrex® AR-13991N
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
128 reports
Arthrex® AR-8981-08S
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall3 reports
Arthrex® AR-8981-06S
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall1 report
Centurion EB16
Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall0 reports
NA Lighthandle Cover
Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall0 reports
Centurion Medical Products Corp SUT15830A
Medline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall0 reports

All INSTRUMENT, MANUAL, SURGICAL, GENERAL USE 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 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