Arthrex® AR-9511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867061828), received between Jun 7, 2021 and Apr 11, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2022Break

  ON 03/22/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9511 IMPACTOR BROKE. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2022. THE BREAK HAPPENED DURING EXTRACTION OF STEM AND SUTURE CUP, THE ADAPTER MALFUNCTIONED AND SNAPPED. NO FRAGMENTS IN PATIENT, SURGERY NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075132 ↗
• MalfunctionNov 8, 2021Break

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE INSIDE THE PATIENT. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 25-OCT-2021: IT WAS CONFIRMED THAT THE THREADED TIP OF THE DEVICE BROKE OFF. UPDATE 27-OCT-2021: THE ACTUALLY AFFECTED DEVICE IS THE AR-9511 (LOT: 051849).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770443 ↗
• MalfunctionJun 7, 2021Break

  IT WAS REPORTED THAT DURING A NANO-CCU/NANO-SPORT SURGERY THE SCREW BROKE INTRA-OPERATIVELY. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PART OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 11946583 ↗