Arthrex® AR-9510RG-5CRecalls & reported problems
Arthrex, Inc. · Reamer Guide Pin, Sz 5 Mod (Neutral) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867280700), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Positioning Failure
ON 10-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510RG-5C SIZE 5 REAMER GUIDE PIN WAS BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. ADDITIONAL INFORMATION PROVIDED 16-FEB-2026: IT WAS FURTHER REPORTED THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE WITH A 10-MINUTE DELAY EXPERIENCED AND NO ADDITIONAL ANESTHESIA ADMINISTERED. PER THE REP, THE DAMAGE IS AT THE BASE OF THE POST, THE POST WILL NOT ENGAGE WITH THE BROACH CORRECTLY. NO PIECES BROKE OFF AND IT WAS STATED NO OBVIOUS INCIDENT CAUSED THIS PROBLEM, JUST SOMETHING THAT WAS NOTICED DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482314 ↗
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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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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