Reform POCT System 55-IN-0110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019926546), received between Mar 30, 2020 and Mar 30, 2020 — classified as 1 injury.

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

• InjuryMar 30, 2020Break; Loose or Intermittent Connection; Device Fell

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2020, "UTIILIZING" THE REFORM POCT SYSTEM. DURING NORMAL USE OF THE ROD REDUCTION ROCKER (55-IN-0110), THE DISTAL END OF THE INSTRUMENT BROKE LOOSE OF THE SHAFT AND FELL INTO THE "PAITIENT". IT WAS RETRIEVED BY USING A BAYONET FORCEP. NO INJURY TO THE PATIENT AND NO REAL TIME WASTED AS A TOWER REDUCER WAS USED TO FINISHED THE JOB QUICKLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898115 ↗