Arthrex® AR-9628SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867350571), received between May 23, 2022 and Sep 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INVERS SHOULDER PROTHESIS SURGERY THE DRILL BROKE AT THE WELDING POINT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061592 ↗
• MalfunctionFeb 18, 2025Break; Break

  ON 01/30/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9628S UNIVERS REVERS¿ MODULAR GLENOID SYSTEM 3.0 MM DRILL BIT FRACTURED. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY WHEN THE TIP OF THE DRILL BIT BROKE OFF INTRAOPERATIVELY. THE MISSING PORTION OF THE DRILL BIT HAS NOT BEEN VISUALLY IDENTIFIED OR VERIFIED POSTOPERATIVELY AND IS POTENTIALLY RETAINED WITHIN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21397871 ↗
• MalfunctionOct 30, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06688062 THAT AN AR-9628S UNIVERS REVERS¿ MODULAR GLENOID SYSTEMS DRILL BIT BROKE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2024. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20565587 ↗
• MalfunctionJun 2, 2023Break; Break

  ON 05/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9628S DRILL BIT BROKE OFF. THIS WAS DISCOVERED DURING A CASE, DEVICE BREAKS DURING USE. PER FACILITY: "THE SURGEON WAS DRILLING FOR A NON-LOCKING PERIPHERAL SCREW AND BELIEVES HE HIT THE POSTERIOR RETRACTOR, IN WHICH THE TIP ENDED UP BREAKING OFF. AFTER THE BASEPLATE WAS REMOVED, HE WAS ABLE TO RETRIEVE THE BROKEN PIECE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054431 ↗
• MalfunctionMar 1, 2023Break; Detachment of Device or Device Component

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9628S MODULAR GLENOID SYSTEM 3.0 MM DRILL SHEERED OFF. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2023 WHEN THE DRILL SHEERED OFF FROM IT'S HUDSON ADAPTER WHILE DRILLING THE GLENOID. THE BROKEN FRAGMENT WAS RETRIEVED, AND THE CASE WAS COMPLETED USING A NEW DRILL. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459008 ↗
• MalfunctionMay 23, 2022Break; Entrapment of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH EMAIL THAT AN AR-9628S UNIVERS REVERS DRILL BIT BROKE OFF IN THE PATIENT'S BONE. THE BROKEN FRAGMENTS WERE NOT RETRIEVED AS THIS WAS IN THE BEST INTEREST OF THE PATIENT. THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON (B)(6) 2022. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14468872 ↗