Arthrex® AR-1644Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867020450), received between Mar 21, 2022 and Jun 19, 2024 — classified as 1 injury, 4 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A DEVICE KIT WHICH EXPIRED ON SEP-2021 CONTAINED BANDAGES WHICH EXPIRED ON SEP-2019. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566807 ↗
• MalfunctionJun 13, 2024Packaging Problem; Packaging Problem

  ON (B)(6) 2022 IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1644 LIMB POSITIONER STERILE PACKAGING WAS PUNCTURED. THIS WAS DISCOVERED BY A NURSE BEFORE OPENING IN THE FIELD WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER STERILE KIT. THIS WAS DISCOVERED DURING RIB RESECTION PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529182 ↗
• MalfunctionMay 23, 2024Component Missing; Component Missing

  ON 09/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-1644 CHAIR KIT IS MISSING THE CLEAR PLASTIC SLEEVE TO DRAPE THE TRIMANO. THIS WAS DISCOVERED UPON OPENING THE PACKAGING AND THERE WAS NO CLEAR PLASTIC SLEEVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386216 ↗
• MalfunctionApr 30, 2024Fitting Problem; Fitting Problem

  ON 11/15/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1644 TRIMANO BEACH CHAIR KIT HAD NO PERFORATION IN THE PART THROUGH WHICH THE ADAPTER OF THE TRANSPARENT STERILIZATION COVER WAS PASSED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. SURGEON COMPLETED CASE WITH A NEW DEVICE AND PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214563 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INJURY OCCURRED AFTER A SURGERY. THE PATIENT SUFFERED FROM A RADIAL PARESIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Paresis

  MAUDE report 13841056 ↗