Arthrex® AR-9202Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867058224), received between Apr 8, 2021 and Mar 17, 2026 — classified as 9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Break

  ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9202 PIN WAS STRUCK WITH A MALLET WHEN REMOVING AND SNAPPED. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618063 ↗
• MalfunctionMar 17, 2026Break

  ON 24-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9202 PIN WAS STRUCK WITH A MALLET WHEN REMOVING AND SNAPPED. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617919 ↗
• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 11/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-9202 UNIVERS/ECLIPSE ORIEN PINS WERE BENT AND UNUSABLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645155 ↗
• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-9202 UNIVERS/ECLIPSE ORIEN PINS WERE BENT AND UNUSABLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645039 ↗
• MalfunctionJul 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 06/18/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9202 ARTHREX ECLIPSE¿ AND UNIVERS¿ ORIENTATION PIN FOR RESECTION GUIDES SHAFT FUSES INSIDE THE REAMER HANDLE. THE T HANDLE WILL NOT ACCEPT THE SMALLER REAMERS. THE PATIENT AND PHYSICIAN WERE NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508994 ↗
• MalfunctionDec 31, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE DEVICE WAS BENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048012 ↗
• MalfunctionJun 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED ON 09/09/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9202 VERSION RODS ARE WORN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478216 ↗
• MalfunctionJun 14, 2021Break; Physical Resistance/Sticking

  IT WAS REPORTED DURING DURING A HEMI SHOULDER ARTHROPLASTY PROCEDURE, THE VERSION ROD BROKE OFF THE AR-9401-13 HEAD CUT GUIDE. THE THREADED PORTION OF THE VERSION ROD IS NOW STUCK INSIDE THE GUIDE. THE CASE WAS STILL SUCCESSFUL AND NO HARM WAS DONE. SEE ATTACHED IMAGES. ADDITIONAL INFORMATION RECEIVED ON 5/26/2021: THE REP PROVIDED THE PART NUMBER OF THE VERSION ROD THAT BROKE DURING THE PROCEDURE (AR-9202). THE VERSION ROD BROKE WHILE THE GUIDE WAS IN USE. THE RODS ARE THREADED INTO THE TOP OF THE GUIDE, AND ARE NOT DIRECTLY IN THE PATIENT BUT ABOVE THE HUMERUS.

  Patient problems: Insufficient Information

  MAUDE report 11990877 ↗
• MalfunctionApr 8, 2021Break

  IT WAS REPORTED THAT THE PIN FROM AR-9207S KIT (LOT:11536563) WAS INTRODUCED INTO THE AR-9401-13 CUT GUIDE. PIN BOUND UP IN CANNULATION CAUSING GUIDE TO SPIN AND BREAKING OFF TWO AR-9202 VERSION RODS. PIN WAS NOT ABLE TO BE REMOVED FROM GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633754 ↗