Arthrex® ABS-1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867306189), received between Feb 7, 2022 and May 22, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN AUTOCART PROCEDURE THE TUBE LOOSENED WITH LIGHT PULL. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. UPDATE AVOE (B)(6) 2023. IT WAS CONFIRMED THAT WHEN THE TUBE CAME OFF, THE SAME NACL FLUID USED TO COLLECT THE CARTILAGE LEAKED OUT AND IN ADDITION THE COLLECTION CONTAINER WAS OPENED, WHERE CARTILAGE COULD STILL BE REMOVED. CONTAMINATION IN THE SENSE OF UNWANTED CONTACT DID NOT OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973088 ↗
• InjuryFeb 7, 2022Defective Device

  IT WAS REPORTED THAT DURING AN AUTOCART PROCEDURE NO THROMBIN WAS PRODUCED. THE MIXTURE COULD NOT BE PRODUCED BECAUSE THE THROMBIN COULD NOT BE DRAWN FROM THE FILTER. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY BY DOING A PRIDIE DRILLING. IT WAS NOT NECESSARY DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472059 ↗