Arthrex® AR-9599FRecalls & reported problems
Arthrex, Inc. · Depth Gauge Full Augment · 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 00888867346192), received between Aug 7, 2025 and Aug 7, 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
Most reported problems
Device problems
- Physical Resistance/Sticking1
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.
MalfunctionAug 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 07/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE AND AN AR-9599F DEPTH GUAGE FULL AUGMENT WERE COLD WELDED TOGETHER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742813 ↗
Other GAUGE, DEPTH devices
- NA 319.006Synthes GmbH · GAUGE, DEPTH899 reports
- NA 03.133.080Synthes GmbH · GAUGE, DEPTH174 reports
- NA 03.010.072Synthes GmbH · GAUGE, DEPTH133 reports
- MULTILOC 03.019.017Synthes GmbH · GAUGE, DEPTH119 reports
- NA 319.01Synthes GmbH · GAUGE, DEPTH113 reports
- NA 319.004Synthes GmbH · GAUGE, DEPTH82 reports
- QUICKSET 2274-60-000Depuy (Ireland) · GAUGE, DEPTH68 reports
- NA 319.09Synthes GmbH · GAUGE, DEPTH65 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.