Arthrex® AR-9202-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867058385), received between May 3, 2018 and Apr 17, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Break; Break

  ON 04/01/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9202-14 UNIVERS¿ 3D SLAPHAMMERS TIP BROKE OFF. THIS OCCURRED DURING A CASE WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857605 ↗
• MalfunctionFeb 13, 2023Break

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9202-14 UNIVERSAL SLAP HAMMER BROKE WHILE REMOVING AN APEX STEM. THE POINTED ATTACHMENT SNAPPED OFF. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361720 ↗
• MalfunctionMay 3, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SMALL BALL AT THE END OF THE AR-9202-14 CAME OFF DURING REMOVAL OF TSA STEM. THE SURGERY WAS COMPLETED AND STEM WAS ABLE TO BE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 11761159 ↗
• MalfunctionApr 19, 2021Break

  IT WAS REPORTED DURING A SHOULDER ARTHROPLASTY REVISION PROCEDURE THAT THE AR-9202-14 SLAP HAMMER BROKE WHILE TRYING TO EXTRACT AN IMPLANT. ANOTHER AR-9202-14 WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE DATE OF THE PRIMARY TOTAL SHOULDER ARTHROPLASTY SURGERY IS UNKNOWN. THE REP STATED THE REASON FOR THE REVISION SURGERY WAS FOR A ROTATOR CUFF ARTHROPLASTY. THE PART AND LOT NUMBERS OF EXPLANTED PRODUCT IS UNKNOWN. ALL EXPLANTED MATERIAL WAS DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 11687036 ↗
• InjuryMay 3, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A TOTAL SHOULDER ARTHROPLASTY PROCEDURE WHERE A UNIVERS II 10MM STEM (LOT: UNKNOWN, LINE: 231362) WAS IMPLANTED. 7 YEARS LATER, THE PATIENT OBTAINED AN INFECTION AT THE INCISION SITE AND UNDERWENT A TOTAL SHOULDER REMOVAL PROCEDURE. DURING THE REMOVAL, THE ATTACHMENT TIP OF THE SLAP HAMMER (LOT: 250150205, LINE 231389) BROKE OFF AFTER ONLY A COUPLE OF USES. THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED, HOWEVER, IT WAS NOT VISIBLE ON THE POST-OP X-RAY. THE SURGEON BELIEVES IT MAY HAVE BEEN REMOVED VIA SUCTION. FOLLOW-UP INVESTIGATION: ORIGINAL SURGERY WAS PERFORMED 7 YEARS AGO. THE DEVICE REMOVED WAS A UNIVERS II 10MM STEM (UNKNOWN LOT #). NOTHING REPLACED THE EXPLANTED STEM AS THE PATIENTS SHOULDER WAS INFECTED. THE PATIENT WAS EXPERIENCING PAIN, PUSS AND A SWOLLEN SHOULDER. THE SALES REP HAS CONFIRMED THAT THE ATTACHMENT BEING USED WITH THE SLAP HAMMER WAS CHECKED AND THE BALL SHAPED TIP THAT IS MISSING FROM THE SLAP HAMMER WAS NOT INSIDE THE ATTACHMENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 7483543 ↗