Arthrex® AR-1510HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867196773), received between Jul 18, 2022 and Oct 15, 2025 — 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Component Missing; Defective Device; Break; Component Missing; Defective Device

  ON 10/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1510HR SIDE RELEASE RETRO CONSTR HANDLE WAS BROKEN. THE TIGHTENING BOLT WAS NOT FUNCTIONING. IT APPEARS THAT THE CROSS BAR KEEPING THE WHEEL IN PLACE WAS MISSING. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302701 ↗
• MalfunctionFeb 20, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON 02/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1510HR RETROCONSTRUCTION DRILL GUIDE HANDLE KNOB PIN FELL OUT AND KNOB CAME OFF. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02/12/2025: THIS OCCURRED DURING A ACL/PCL PROCEDURE ON (B)(6)2025. THE KNOB WAS FOUND BUT THEY COULD NEVER FIND THE PIN. AN X-RAY WAS TAKEN TO MAKE SURE IT WASN¿T IN THE PATIENT. THE CASE WAS COMPLETED USING A NEW ACL SET AND A AR-1510HR RETROCONSTRUCTION DRILL GUIDE HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS A TWENTY MINUTE DELAY IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421539 ↗
• MalfunctionJul 18, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE SURGEON WANTED TO USE THE HANDLE OF THE VIEWFINDER, HE DID NOT SUCCEED IN UNSCREWING THE KNOB. IT WAS BLOCKED, WHEREAS USUALLY, IT WAS EASILY UNSCREWED. BY FORCING TO SUCCEED IN UNSCREWING IT, THE KNOB ENDED UP BREAKING. 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. UPDATE AVOE 27-JUN-2022: IT WAS CONFIRMED THAT A PART OF THE DEVICE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041085 ↗