Arthrex® AR-11890Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867003774), received between Sep 24, 2018 and Dec 3, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Break; Break

  ON 11/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-11890 BIRDBEAK BROKE UPON INSERTION IN THE BICEP. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707324 ↗
• MalfunctionOct 24, 2022Break

  THIS IS A CONVERSION FROM CC195923, LINE 299787. AN CUSTOMER UPDATE WAS RECEIVED WHICH MADE A REPAIR TO A COMPLAINT. THE CUSTOMER STATED THE TIP BROKE-OFF DURING A SURGERY. FURTHER INFORMATION REQUESTED. NO NEW INFORMATION GIVEN AT THIS TIME. 21-OCT-2022 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A SHOULDER ARTHROSCOPY. THE SURGERY COULD BE FINISHED SUCCESSFULLY AND MOST LIKELY THE BROKEN PART REMAINED ATTACHED TO THE DEVICE OR COULD BE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 15657382 ↗
• InjuryOct 1, 2019Material Protrusion/Extrusion; Packaging Problem

  IT WAS REPORTED BY THE ARTHREX SERVICE COMPLAINTS TECH II, THAT AN INCIDENT OCCURRED ON (B)(6) 2019 INVOLVING A COMPLAINT DEVICE FOR CASE (B)(4) THAT WAS BEING RECEIVED AT THE ARTHREX SERVICE CENTER (ACI). WHILE THE SERVICE COMPLAINTS TECH II WAS RECEIVING THE COMPLAINT DEVICE, WHICH WAS PACKAGED IN A BOX, THE INDIVIDUAL WAS INJURED. THE EMPLOYEE WAS CUT BY THE COMPLAINT DEVICE WHEN IT WAS UNNOTICED THAT THE COMPLAINT DEVICE TIP WAS STICKING THROUGH THE SHIPPING BOX. THE DEVICE WAS SHIPPED TO ARTHREX BY THE MEDICAL FACILITY WHICH PACKAGED THE ITEM. THE COMPLAINT DEVICE, AR-11890, (BIRDBEAK 2.75MM 22 DEGREE UP TIP) IS A SHARP OBJECT AND SHOULD HAVE BEEN PROPERLY PACKAGED AS SUCH PRIOR TO SHIPPING.

  Patient problems: Injury

  MAUDE report 9141746 ↗
• InjurySep 24, 2018Break; Component Missing

  IT WAS REPORTED THAT AFTER USE IN A ROTATOR CUFF REPAIR PROCEDURE THE AR-11890 BIRD BEAK DEVICE WAS RETURNED TO THE DISTRIBUTOR OFFICE. UPON RETURN TO THE DISTRIBUTOR IT WAS NOTICED THAT THE DEVICE HAD A BROKEN TIP. THE MISSING PIECE WAS SMALL AND WAS NOT NOTICED AS MISSING AT THE TIME OF PROCEDURE, THEREFORE NO ATTEMPT WAS MADE TO RETRIEVE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901745 ↗