Arthrex® AR-5400-400NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867321403), received between Feb 3, 2025 and Feb 16, 2026 — classified as 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 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 16, 2026Break

  ON 28-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-400NS DYNANITE® VIP¿ GLENOID PIN BROKE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2026, THE BROKEN GUIDE WIRE WAS NOTICED ON POSTOPERATIVE X-RAY, NOT INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS PROVIDED ON 02-FEB-2026 WHERE THE SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE PATIENT HAD NORMAL BONE QUALITY. THE PATIENT'S BONE WAS PREPPED USING THE AR-5400-400NS GLENOID PIN, AR-5400-S VIP GLENOID TARGETER SET, AR-5410-01 VIP¿ GLENOID REAMER, VIP¿ AUGMENTED MGS REAMER, AR-9596-1025F MODULAR DRILL, AND AN AR-9582-25 MODULAR POST FOR AUGMENTED MGS BASEPLATE 25 MM. THE PROCEDURE WAS COMPLETED WITH STANDARD PROCEDURAL TECHNIQUE USING RTSA, VIP, AND AUGMENTED MGS SETS. THERE WAS NO DELAY IN THE CASE. ADDITIONAL INFORMATION WAS PROVIDED ON 03-FEB-2026 WHERE THE SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ADDITIONAL SURGERY TOOK PLACE ON (B)(6) 2026 TO REMOVE THE BROKEN AR-5400-400NS DYNANITE VIP GLENOID PIN. IT WAS NOTED THAT THE PATIENT WAS DOING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24345037 ↗
• MalfunctionNov 13, 2025Break; Break

  ON 10/29/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-400NS 2.8 MM DYNAMITE VIP GLENOID NITINOL PIN BROKE OFF INSIDE A PATIENT DURING AN RSA PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, BUT THE BROKEN PIECE WAS NOT RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23541863 ↗
• MalfunctionFeb 13, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-400NS DYNANITE VIP GLENOID PIN SNAPPED AT THE 35MM MARK WHILE REAMING THE CENTRAL POST HOLE FOR AN AUGMENTED MGS BASEPLATE. THE SURGEON COULD NOT RETRIEVE THE PIN AND ATTEMPTED TO PALPATE THE PIN ANTERIOR TO THE GLENOID BUT COULD NOT FEEL THE PIN. A MINI C-ARM WAS BROUGHT INTO THE ROOM TO LOCATE THE BROKEN PIN. THE SURGEON RANGED THE HUMERUS AND NOTED THE PIN STAYED STATIONED WITH HUMERAL ROM. THEN, THE SURGEON MOVED THE SCAPULA, AND THE PIN WAS MOVED ON THE X-RAY IN A SCAPULAR MOTION. THE SURGEON ASSESSED THAT THE PIN MUST HAVE BEEN IN THE SCAPULA, NOT SOFT TISSUE. THE PIN WAS LEFT, AND THE SURGEON COMPLETED THE REST OF THE CASE AS PLANNED. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 01/29/2025: THE PROPER TECHNIQUE WAS FOLLOWED PER THE ARTHREX TECHNIQUE GUIDE TO COMPLETE THE CASE. THERE WAS A TWENTY-MINUTE CASE DELAY IN GETTING A MINI C ARM DRAPED AND POSITIONED IN THE ROOM AND DETERMINING WHERE THE PIN WAS. THERE WAS NO INFORMATION ON ADDITIONAL ANESTHESIA BEING ADMINISTERED TO THE PATIENT. THERE WAS NO UNPLANNED INCISION D

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375186 ↗
• MalfunctionFeb 3, 2025Break; Break

  ON (B)(6)2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-400NS DYNANITE® VIP¿ GLENOID PIN BROKE. THIS OCCURRED DURING A SHOULDER PLACEMENT PROCEDURE THE PIN WAS LODGED DEEP IN THE BONE AND MUSCLE. THEY RECOGNIZED THE HARDWARE FAILURE IMMEDIATELY. THE REMOVAL OF THE PIN WOULD HAVE CAUSED MORE DAMAGE TO THE PATIENT AS WOULD HAVE LIKELY NEEDED TO CREATE A LARGE BORE HOLE IN THE GLENOID BONE OR CUT THE GLENOID IN HALF IN ORDER TO REMOVE THE PIN. THEY DECIDED AGAINST REMOVAL SECONDARY TO INCREASED HARM TO THE PATIENT AND OPTED TO LEAVE THE PIN AND MONITOR WITH REPEAT XRAYS AT REGULAR INTERVALS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21297094 ↗