Arthrex® AR-5400-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867315457), received between Oct 1, 2024 and Apr 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Accessory Incompatible; Inadequacy of Device Shape and/or Size; Accessory Incompatible; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A FRACTURE REVERSE SHOULDER REPLACEMENT WHEN ATTEMPTING TO BUILD THE VIP JIG THE SIZE 18 LEG TOO BIG TO FIT THE HOLE IN THE HANDLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872384 ↗
• MalfunctionMar 26, 2025Defective Device; Defective Device

  ON 03/03/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-02 VIP¿ GLENOID TARGETER HANDLE SLID EVEN THOUGH BOTH NUTS WERE SECURED TIGHTLY. AR-5400-04 VIP¿ GLENOID TARGETER LOCKING NUT, AND A SECOND NUT FROM THE AR-4500-S SET. THIS OCCURRED DURING A REVERSE SHOULDER ARTHROPLASTY ON (B)(6)2025. ADDITIONAL INFORMATION WAS PROVIDED ON 03/04/2025 WHERE THE SALES REPRESENTATIVE STATED THE ARMS THAT DIDN¿T HOLD IN PLACE WERE 10,12,15,18,25. CLARIFICATION: IT WAS REPORTED THAT THE TARGETER ARMS, AR-5400-10, AR-5400-12, AR-5400-15, AR-5400-18, AND AR-5400-25 WERE SLIDING ON THE HANDLE, DESPITE BOTH NUTS BEING SECURELY TIGHTENED.

  Patient problems: Insufficient Information

  MAUDE report 21696582 ↗
• MalfunctionOct 1, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 09/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06667505 THAT AN AR-5400-18 VIP¿ GLENOID TARGETER WAS BENT. THIS OCCURRED DURING A CASE WHERE THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346472 ↗