Arthrex® AR-9507RGDP-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867266025), received between Jul 27, 2021 and Aug 16, 2023 — classified as 2 malfunctions.

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

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.

• MalfunctionAug 16, 2023Difficult to Advance; Difficult to Advance

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9507RGDP-3 UNIVERS REVERS HUMERAL RESECTION GUIDE MALFUNCTIONED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023. DURING HUMERAL PREPARATION, WHEN SECURING THE COMPROMISED RESECTION GUIDE WITH THE 2.4MM BREAKAWAY PINS TO THE PATIENT, THE SURGEON HAD DIFFICULTY DRIVING THE APPROPRIATELY DESIGNATED 2.4MM PIN THROUGH ONE OF THE AVAILABLE RESECTION GUIDE HOLES. A COUPLE OF ALTERNATIVE 2.4MM PINS WERE ATTEMPTED WITHOUT SUCCESS. THE CASE DELAY WAS APPROXIMATELY 1 MINUTE WHILE ALTERNATIVE HOLES WERE UTILIZED. POST-SURGICAL INSPECTION APPEARED TO SHOW A METAL BURR WITHIN THE RESECTION HOLE PREVENTING THE PINS FROM BEING DRIVEN. THE INSTRUMENT DID NOT BREAK. THERE WAS NOT AN UNPLANNED INCISION. A SECOND SURGERY WAS NOT NECESSARY. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: NOTHING BROKE INSIDE THE PATIENT. WHEN THE DEVICE WAS INSPECTED POST-SURGICALLY AND OUTSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556182 ↗
• MalfunctionJul 27, 2021Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A UNIVERS REVERS SHOULDER SURGERY WIRES GOT STUCK IN THE HOLES OF THE DEVICE AND BROKE OFF. NO BROKEN PARTS WERE LOOSE INSIDE THE PATIENT AND HAD TO BE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY BY SAWING FREEHAND. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231939 ↗