Arthrex® AR-5400-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867315334), received between Apr 8, 2024 and Mar 10, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Positioning Failure

  ON 17-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-01 GLENOID TARGETER SHAFT SLOT B IN THE SHAFT DID NOT HOLD THE LEG PROPERLY. THE LEG WAS SLIDING FREELY IN THE B SLOT OF THE SHAFT, MAKING IT DIFFICULT TO KEEP THE LEG IN THE PROPER POSITION. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558145 ↗
• MalfunctionDec 31, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 10-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT WHEN TRYING TO ASSEMBLE THE VIP GLENOID TARGETER, SLOT B OF THE AR-5400-01 GLENOID TARGETER SHAFT WAS DENTED, AND THE TARGETER LEG COULD NOT BE INSERTED ONTO THE TARGETER SHAFT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933833 ↗
• MalfunctionAug 25, 2025Corroded; Use of Device Problem; Corroded; Use of Device Problem

  ON 08/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-01 GLENOID TARGETER SHAFT HAD AN ISSUE. THEY HAD TROUBLE LOADING THE TARGETING LEG INTO THE VIP TARGETER. IT WAS NOTICED THAT THERE WAS A BURR ON THE D SLOT OF THE TARGETING LONG PIECE (AR-5400-01) AND THE MARKING BETWEEN D-08 AND D-12 WAS BARELY VISIBLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884044 ↗
• MalfunctionAug 14, 2025Positioning Failure; Positioning Failure

  ON 07/29/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-01 VIP GLENOID TARGETER SHAFT ARM WOULD NOT SLIDE DOWN THE SLOTS. THIS OCCURRED DURING AN RTSA, AND NO PATIENT WAS HARMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803709 ↗
• MalfunctionAug 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 07/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-01 GLENOID TARGETER SHAFT DID NOT ALLOW LEGS TO SLIDE DOWN IT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727938 ↗
• MalfunctionJun 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-01 GLENOID TARGETER SHAFT DID NOT ALLOW THE ARMS TO SLIDE IN CORRECTLY, AND AN AR-9594-2410 BASEPLATE WAS WORN. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213614 ↗
• MalfunctionSep 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 09/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-01 VIP GLENOID TARGETER WOULD NOT ALLOW ANY OF THE ARMS TO SLIDE DOWN SLOT C. THE CASE WAS COMPLETED SUCCESSFULLY USING A BACK UP TRAY WITHOUT ANY ISSUES. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249208 ↗
• MalfunctionJun 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON 01/30/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-5400-01 GLENOID TARGETER IS STICKING. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457578 ↗
• MalfunctionMay 22, 2024Use of Device Problem; Use of Device Problem

  ON 08/19/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-5400-02 GLENOID TARGETER HANDLE AND AN AR-5400-01 GLENOID TARGETER SHAFT HAD AN ISSUE. DURING AN UNSPECIFIED PROCEDURE, THE AR-5400-01 GLENOID TARGETER SHAFT SLOT A WOULD NOT ALLOW THE ARM TO SLIDE IN, AND THE AR-5400-02 GLENOID TARGETER HANDLE WOULD NOT ALLOW THE ARM TO SLIDE INTO THE A SLOT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. ON 08/31/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THIS EVENT OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2022. THE SURGEON USED A HEMOSTAT TO GUIDE THE DEVICE INTO THE A SLOT, AND BOTH DEVICES THEN WERE USED TO COMPLETE THE CASE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THESE INSTRUMENTS COULD NOT BE USED ANYMORE AFTER THE COMPLETION OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370931 ↗
• MalfunctionMay 2, 2024Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ON 04/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5400-01 GLENOPID TARGETER SHAFT IS NOT LOCKING INTO THE LEG. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235030 ↗
• MalfunctionApr 23, 2024Defective Device; Defective Device

  ON 3/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06526980 THAT AN AR-5400-01 GLENOID TARGETER SHAFT "B" SLOT WAS NOT LOCKING DOWN WITH A LEG PLACED IN IT WHEN SETTING UP WITH THE SCRUB TECH. THEY TIGHTENED THE CAPTURE NUT AND THE LEG, BUT WOULD STILL NOT LOCK IN. THEY TRIED USING MANY LEGS OF DIFFERENT SIZES TO SEE IF THIS WAS THE ISSUE, BUT IT PERSISTED. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED WHEN SETTING UP WITH THE SCRUB TECH FOR A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163991 ↗
• MalfunctionApr 8, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 03/18/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-5400-01 GLENOID TARGETER SHAFT BROKE DURING USE FROM STANDARD USAGE, AND THE GUIDE WAS BENT DURING THE CASE, WITH NO FURTHER INFORMATION PROVIDED. NO PIECES BROKE INSIDE THE PATIENT, AND THE CASE WAS COMPLETED WITHOUT COMPLICATIONS. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 3/28/2024: DUE TO THE HANDLE OF THE AR-5400-01 GLENOID TARGETER SHAFT BEING BENT, THE TARGETING LEGS WERE UNABLE TO SLIDE INTO THE ARM SLOTS OF THE AR-5400-01 GLENOID TARGETER SHAFT. THE CASE WAS COMPLETED USING A DIFFERENT HANDLE WITH NO DELAY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 3/29/2024: FURTHER CLARIFICATION WAS RECEIVED THAT THE "BENT" DEVICE WAS THE AR-5400-01, TARGETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060792 ↗