Arthrex® AR-9127-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867057630), received between Jun 18, 2024 and Jun 19, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 16, 2026.

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.

• MalfunctionJun 19, 2024Component Missing; Component Missing

  ON 5/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9127-01 ARTHREX UNIVERSAL GLENOID CORING REAMER WAS MISSING THE WHITE-CENTERED KNOB AND WAS DISCOVERED DURING THE CASE. THE CASE WAS COMPLETED BY UNTHREADING ONE FROM THE MEDIAL REAMER AND PUTTING IT ON THE SMALL REAMER TO FINISH THE CASE AND NOTHING BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 5/29/2024: THERE WAS NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565867 ↗
• MalfunctionJun 18, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A UNIVERS REVERSE PROSTHESIS SURGERY THE DEVICE WAS DULL AND THE WHITE INSERTION PLUG WAS MISSING. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559565 ↗