NA 03.404.031SRecalls & reported problems
Synthes GmbH · 17.5MM REAMER HEAD FOR RIA 2 STERILE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982274076), received between Jan 18, 2024 and Jan 18, 2024 — classified as 1 injury.
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 16, 2026.
Reports received per month
Recalls naming this device
- Nov 19, 2020Terminated
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-0586-2021 · Root cause: Use error · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON DEC 19, 2023, REAMER RIA 2 (REAMER IRRIGATOR ASPIRATOR) SIZE 17MM RIA HEAD WAS USED DURING THE CASE. THE PATIENT HAD RIA 2 PROCEDURE PERFORMED FOR VASCULAR SURGERY. SALES REP DID NOT KNOW THE CAUSE FOR VASCULAR SURGERY INJURY AS IT WAS FROM RIA 2 DEVICE. THERE WAS PATIENT INVOLVEMENT. THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 17.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Perforation of Vessels
MAUDE report 18537144 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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