Arthrex® AR-1250LTSRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867239432), received between Aug 17, 2020 and Aug 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of 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 18, 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 17, 2020Entrapment of Device; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE 3MM SUTURETAK SHAVER DRILL, AR-1250LTSR, WAS BEING USED WITH A DISPOSABLE FISH MOUTHED DRILL GUIDE AND METAL SHAVINGS WERE NOTED IN THE JOINT AFTER DRILLING. THE SURGEON WAS ABLE TO CLEAR ALL SHAVINGS WITH A SHAVER. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 07/29/2020: TYPE PF PROCEDURE BEING PERFORMED WAS A LEFT SHOULDER STAB. THE RPM WAS SET TO 6200RPM IN FWD. THE HOSPITAL REFUSED TO ALLOW DUALWAVE INTO SUPPORT THE SHAVER SYSTEM SO FMS DUO WAS IN USE. THERE WAS NO INTERRUPTION IN THE FLOW OF IRRIGATION. SURGEON USED BONECUTTER 4MM SHAVER TO RETRIEVE ANY METAL SAVINGS HE COULD SEE AND THE CASE CONCLUDED AS NORMAL. ADDITIONAL INFORMATION PROVIDED 08/4/2020: THE REPORTER IS NOT 100% SURE THAT ALL FRAGMENTS WERE RETRIEVED; HOWEVER, THERE WERE CERTAINLY NONE VISIBLE IN THE SURGEONS FIELD OF VISION AT THE TIME THE CASE ENDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10414335 ↗