Arthrex® AR-1938DHDRecalls & reported problems

Arthrex, Inc. · 3.0 Knotless Hip SutureTak Disp Drill HB · Class 1

Data updated Oct 13, 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 00888867253933), received between Sep 4, 2025 and Sep 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

Material Fragmentation1

Patient problems

Foreign Body In Patient1
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 4, 2025Material Fragmentation; Material Fragmentation
ON 08/15/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1938DHD KNOTLESS HIP SUTURETAK DISP. DRILL HB EXPERIENCED A MALFUNCTION. DURING A HIP ARTHROSCOPY PROCEDURE, WHILE THE SURGEON WAS DRILLING DIRECTLY INTO THE BONE WITHOUT APPLYING ANY SIDE-TO-SIDE TORQUE OR TWEAKING MOTION, METALLIC FRAGMENTS WERE OBSERVED EMERGING FROM THE DRILL BIT. IT WAS CONFIRMED THAT THE STANDARD TECHNIQUE WAS FOLLOWED AND THE OCCURRENCE WAS UNEXPECTED. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22964717 ↗

Device details

UDI-DI	`00888867253933`
Brand	Arthrex®
Model	AR-1938DHD
Company	Arthrex, Inc.
Product code	HTW · BIT, DRILL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 28, 2022

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

A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

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All BIT, DRILL 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.

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