Arthrex® ABS-3008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867084407), received between Feb 1, 2021 and Feb 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2021Contamination; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE THE BLACK PLUNGER TOP OF THE ABS-3008,QUICKSET KIT (LOT 19HAR1191), POPPED OUT OF THE DUAL-CHAMBERED SYRINGE TUBE WHEN EXPELLING THE AIR/ MIGRATING THE CALCIUM PHOSPHATE MIXTURE UP TO THE TIP OF THE DUAL-CHAMBERED SYRINGE. THE BLACK PLUNGER TOP POPPED OUT AND HIT THE SURGEON'S FACE SHIELD, RICOCHETING AND CONTAMINATING THE DEVICE ITSELF AND THE BACK TABLE AS WELL. THEY WERE ABLE TO FINISH THE PROCEDURE WITH A NEW ABS-3005 QUICKSET KIT FROM THE FACILITY INVENTORY. THERE ARE NO PICTURES OF THE COMPLAINT DEVICE AND THE COMPLAINT DEVICE IS NOT ABLE TO BE RETURNED FOR EVALUATION. THE STAFF IMMEDIATELY DRAPED AND DISCARDED THE PRODUCT. THE PROCEDURE WAS A HARDWARE REMOVAL OF ANOTHER MANUFACTURER'S PROXIMAL HUMERUS PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258731 ↗