NA 03.404.025SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982274083), received between Nov 4, 2020 and Dec 11, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 19, 2020Class IITerminated

   RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

   Z-0580-2021 · Root cause: Use error · Recall details · FDA record ↗

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.

• InjuryDec 11, 2020Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS USING THE REMER IRRIGATOR ASPIRATOR (RIA) SYSTEM AND THE ASSEMBLY BROKE OFF DURING THE REAMING PROCESS. THE SURGEON WAS UNABLE TO COMPLETE HARVESTING AND OBTAINED NO GRAFT FOR USE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGERY ENDED FINE AND THE PATIENT WAS STABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 14.5MM REAMER HEAD FOR RIA 2 STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10993525 ↗
• MalfunctionNov 4, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE REAMING WITH A RIA2 FOR BONE GRAFT, THE REAMER HEAD FOR RIA 2 TIP BROKE WHILE TAKING THE REAMER BACK OUT AFTER THE FIRST PASS. NO UNDUE TORQUE NOR ANGULATION WAS APPLIED SINCE IT WAS AN INTACT FEMUR. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 14.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10786893 ↗