Arthrex® AR-9530M-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867062108), received between Mar 14, 2022 and Jan 12, 2026 — classified as 8 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Break

  ON 19-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530M-03 UNIVERS REVERS TRIAL WAS CHIPPED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036835 ↗
• MalfunctionJul 9, 2025Break; Break

  ON 06/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530M-03 UNIVERS REVERS TRIAL WAS BADLY CHIPPED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 22455668 ↗
• MalfunctionJul 9, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530M-03 UNIVERS REVERS TRIAL BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455650 ↗
• MalfunctionApr 23, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER SURGERY THE TWO OPENINGS BECAME WAY BIGGER THEN INTENDED AND THE PLIER DID NOT HOLD PROPERLY ANYMORE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892321 ↗
• MalfunctionMay 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE AR-9530M-03. ADDITIONAL INFORMATION (B)(6) 2021 IT WAS REPORTED THAT THE AR-9530M-03, POLY HAD A BIG CHIP OUT OF IT AND WAS THROWN AWAY AND THE AR-611-4, IMPACTOR HAS A SMALL CRACK.

  Patient problems: Insufficient Information

  MAUDE report 19358306 ↗
• MalfunctionSep 14, 2023Break; Break

  ON 8/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A QUANTITY OF 2 AR-9530M-03 UNIVERS REVERS, TRIAL HUMERAL INSERT FROM DIFFERENT LOTS HAD AN ISSUE. THE SURGEON TRIED TO USE THE DEVICE DURING A TRIAL AND SNAPPED IN THE MIDDLE OF THE CASE. ALL THE FRAGMENTS WERE RETRIEVED, AND NOTHING WAS LEFT INSIDE THE PATIENT. THE CASE WAS DELAYED FOR ONE MINUTE AND CONTINUED USING ANOTHER OF THE SAME ARTHROPLASTY DEVICE. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745970 ↗
• MalfunctionSep 14, 2023Break; Break

  ON 8/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A QUANTITY OF 2 AR-9530M-03 UNIVERS REVERS, TRIAL HUMERAL INSERT FROM DIFFERENT LOTS HAD AN ISSUE. THE SURGEON TRIED TO USE THE DEVICE DURING A TRIAL AND SNAPPED IN THE MIDDLE OF THE CASE. ALL THE FRAGMENTS WERE RETRIEVED, AND NOTHING WAS LEFT INSIDE THE PATIENT. THE CASE WAS DELAYED FOR ONE MINUTE AND CONTINUED USING ANOTHER OF THE SAME ARTHROPLASTY DEVICE. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745478 ↗
• MalfunctionMar 14, 2022Break; Difficult to Remove

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9530M-03 UNIVERS REVERS TRIAL 39 +3 WAS DAMAGED. WHEN TRYING TO REMOVE THE TRIAL ON (B)(6) 2022, IT GOT STUCK AFTER RE-DISLOCATING THE ARM. AS HE WAS GETTING THE INSERT OUT, DAMAGED THE PLASTIC TRIAL INSERT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. ON 02/24/2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THE EVENT OCCURRED IN A REVERSE TSA PROCEDURE, THE DAMAGE OCCURRED WHILE TRYING TO REMOVE THE DEVICE. THE PART BROKE INSIDE THE PATIENT, NO FRAGMENTS WERE LEFT BEHIND. TO COMPLETE THE PROCEDURE, ANOTHER POLY WAS OPENED, AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757961 ↗