Arthrex® AR-9236-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867059481), received between Aug 14, 2019 and Feb 4, 2025 — classified as 1 injury, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02 PEGGED GLENOID BROKE. THIS OCCURRED DURING USE UPON IMPACTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21303619 ↗
• MalfunctionMay 3, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9236-02 GLENOID TRIAL CENTRAL PEG BROKE OFF IN THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS WERE REMOVED. DELAY IN CASE 20 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240198 ↗
• MalfunctionJul 3, 2023Break; Break

  ON 06/07/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-02 TRIAL BROKE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED ON 6/14/2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17248124 ↗
• InjuryAug 14, 2019Positioning Failure; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TRUNNION OF THE AR-9100-06P UNIVERS II STEM (SIZE 6) WOULD NOT REMAIN ENGAGED WITH THE PROXIMAL STEM BODY TO FACILITATE STEM EXTRACTION DURING A TSA REVISION TO RSA PROCEDURE. AFTER SEVERAL ATTEMPTS TO RE-ENGAGE, THE TRUNNION WOULD STILL NOT ENGAGE. A SEPARATE STEM AR-9100-13P (LOT:16.00283) WAS OPENED AND THAT TRUNNION WAS USED TO SUCCESSFULLY EXTRACT THE STEM FROM THE PATIENT WITHOUT FURTHER PROBLEMS. THE COMPLAINT DEVICE WILL BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 07/29/2019: THE REP STATED THE REVISION PROCEDURE WAS DUE TO THE PATIENT FALLING AND TEARING THEIR SUBSCAPULARIS. THE SURGEON DETERMINED A REVISION WAS THE BEST PLAN OF ACTION. PRIOR TO THE REVISION PROCEDURE TAKING PLACE THE PATIENT WAS EXPERIENCING DISCOMFORT DUE TO CHRONICALLY DISLOCATING THEIR SHOULDER AS A RESULT OF THE TORN ROTATOR CUFF. THE REP STATED THE DATE OF THE FALL IS UNKNOWN. THE PRIMARY ANATOMIC TSA PROCEDURE TOOK PLACE IN (B)(6) 2018, AND WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE REVISION AND TOOK PLACE AT THE SAME FACILITY. THE BONE QUALITY WAS MEDIUM. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE, AND EXPLANTED DURI

  Patient problems: Discomfort; Fall; Injury; Joint Disorder

  MAUDE report 8893676 ↗