Arthrex® AR-9100-10PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867057128), received between May 3, 2018 and Feb 17, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Physical Resistance/Sticking

  ON 29-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9100-10P HUMERAL STEM INSERTER SCREW WOULD NOT ADVANCE INTO THE STEM AND BECAME STUCK. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. DELAY IN CASE 15 MINUTES. CASE WAS COMPLETED USING SIZE 11 STEM.

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

  MAUDE report 24363699 ↗
• MalfunctionFeb 17, 2026Physical Resistance/Sticking

  ON 29-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9100-10P HUMERAL STEM INSERTER SCREW WOULD NOT ADVANCE INTO THE STEM AND BECAME STUCK. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. DELAY IN CASE 15 MINUTES. CASE WAS COMPLETED USING SIZE 11 STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363673 ↗
• InjuryMay 3, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A TOTAL SHOULDER ARTHROPLASTY PROCEDURE WHERE A UNIVERS II 10 MM STEM (LOT: UNKNOWN, (B)(4)) WAS IMPLANTED. SEVEN (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, (B)(4)) 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 10 MM 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 7483542 ↗