Arthrex® ABS-1981-16SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867295292), received between Aug 20, 2020 and Aug 20, 2020 — classified as 1 injury.

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

• InjuryAug 20, 2020Fitting Problem

  IT WAS REPORTED BY THE SALES REP, WHO WAS PRESENT, THAT DURING A (B)(6) 2020 OCA CASE 16MM FRESH PLUGS FROM LIFENET (LIFENET ID: 2017189-7006, CODE: RFP16, EXP: 2020-08-14) AND AN ARTHREX 16MM OATS DISPOSABLE KIT, ABS- 1981-16S (LOT 10634212) WERE BEING USED. SURGEON IS WELL ACCUSTOMED TO ARTHREX OATS TECHNIQUES AND HAS PERFORMED MANY MEGA OATS CASE AND AUTOGRAFT OATS CASE WHERE ALL THE IMPLANTATION ARE PRESS FIT AS WELL. THE TECHNIQUE WHERE THE KIT AND PLUG ARE USED TOGETHER IS A PRESS FIT IMPLANTATION. WHEN THE PLUG WAS INSERTED DURING THIS PROCEDURE REPORTER STATES THEY COULD VISUALIZE THE INFERIOR BORDER OF THE PLUG WHICH WAS DESCRIBED TO BE NO WHERE NEAR PRESS FIT, YET EVEN LINE TO LINE WITH THE BORDER. REPORTER STATES ALL CORRECT TECHNIQUE PROTOCOLS FOR REAMING THE RECIPIENT HOLE AND THEN USING THE ALIGNMENT ROAD. SURGEON DOUBLE CHECK THE MEASUREMENTS OF THE FOUR QUADRANTS TWICE TO CONFIRM THE DEPTH OF THE DESIRED PLUG. REPORTER STATES HE WAS UNSURE IF THE MALFUNCTION WAS ON THE KIT DIES OR THE ACTUAL PLUG SIDE OF THE PROCEDURE. IN ORDER TO ACHIEVE DESIRED FIXATION A HEADLESS COMPRESSION SCREW WAS USED AS THE PLUG BY ITSELF WAS WOBBLY. PATIENT WAS REPORTED TO BE YOUNG AND HEA

  Patient problems: No Code Available

  MAUDE report 10431314 ↗