Arthrex® AR-1646Recalls & reported problems
Arthrex, Inc. · TRIMANO ELBOW KIT · Class 1
- 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 00888867020474), received between May 22, 2024 and May 22, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Contamination1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2024Contamination; Contamination
IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE STERILE PACKAGING OF THE AR-1646.
Patient problems: Insufficient Information
MAUDE report 19372747 ↗MalfunctionMay 22, 2024Component Missing; Component Missing
ON 07/22/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA (B)(4) THAT A AR-1646 ELBOW KIT WAS OPENED AND THE STERILE DRAPE WAS MISSING. THIS WAS DISCOVERED DURING AN UNKNOWN CASE. A SECOND KIT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19371085 ↗
Other Table and attachments, operating-room devices
- Arthrex® AR-1747-BArthrex, Inc. · TABLE AND ATTACHMENTS, OPERATING-ROOM12 reports
- Arthrex® AR-1644Arthrex, Inc. · Table and attachments, operating-room5 reports
- Leg holder 100380A0MAQUET GmbH · TABLE AND ATTACHMENTS, OPERATING-ROOM4 reports
- Arthrex® AR-1560-02Arthrex, Inc. · TABLE AND ATTACHMENTS, OPERATING-ROOM4 reports
- Arthrex® AR-1500Arthrex, Inc. · TABLE AND ATTACHMENTS, OPERATING-ROOM3 reports
- Pair of leg plates 113373BCMAQUET GmbH · TABLE AND ATTACHMENTS, OPERATING-ROOM3 reports
- Kneeling frame 100704D0MAQUET GmbH · TABLE AND ATTACHMENTS, OPERATING-ROOM2 reports
- Traction boot, adult 10018800MAQUET GmbH · TABLE AND ATTACHMENTS, OPERATING-ROOM2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.