Arthrex® AR-9400-SBKRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867356733), received between May 24, 2021 and Jan 13, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Positioning Failure; Positioning Failure

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM DID NOT GET SUFFICIENT FIXATION WITH THE ECLIPSE TRUNION AND CAGE SCREW. THE CASE WAS COMPLETED USING A LONG STEM. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 12/30/2024: THE PART NUMBERS AR-9301-02 AND CAGE SCREW AND AR-9301-45CPC ARTHREX ECLIPSE TRUNION WERE PROVIDED. ADDITIONALLY, THE SALES REPRESENTATIVE REPORTED THAT ANOTHER AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM FROM A DIFFERENT LOT NUMBER AND AN AR-9301-01 ARTHREX ECLIPSE CAGE SCREW WAS ATTEMPTED TO BE USED AS WELL BUT STILL COULD NOT GET SUFFICIENT FIXATION. THE CASE WAS COMPLETED USING AN AR-9100-05M UNIVERS APEX OPTIFIT HUMERAL STEM. THE CASE WAS DELAYED BETWEEN THIRTY TO FORTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 21138145 ↗
• MalfunctionJan 13, 2025Positioning Failure; Positioning Failure

  ON 12/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM DID NOT GET SUFFICIENT FIXATION WITH THE ECLIPSE TRUNION AND CAGE SCREW. THE CASE WAS COMPLETED USING A LONG STEM. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/30/2024: THE PART NUMBERS AR-9301-02 AND CAGE SCREW AND AR-9301-45CPC ARTHREX ECLIPSE TRUNION WERE PROVIDED. ADDITIONALLY, THE SALES REPRESENTATIVE REPORTED THAT ANOTHER AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM FROM A DIFFERENT LOT NUMBER AND AN AR-9301-01 ARTHREX ECLIPSE CAGE SCREW WAS ATTEMPTED TO BE USED AS WELL BUT STILL COULD NOT GET SUFFICIENT FIXATION. THE CASE WAS COMPLETED USING AN AR-9100-05M UNIVERS APEX OPTIFIT HUMERAL STEM. THE CASE WAS DELAYED BETWEEN THIRTY TO FORTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 21136891 ↗
• MalfunctionJun 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FIVE ANCHORS FROM THE AR-9400-SBK SUBSCAP SYSTEM WOULD NOT SEAT; THEY EACH PULLED OUT. THEY USED A SPEEDBRIDGE TO COMPLETE THE CASE. THE SAME SITE WAS USED; THERE WERE NO ADDITIONAL INCISIONS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528036 ↗
• MalfunctionJun 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ANCHOR WOULD NOT SEAT; THE SAME SITE WAS USED WITH A SWIVELOCK TO COMPLETE THE RCR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526769 ↗
• MalfunctionJun 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/04/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AR-9400 SBK IMPLANT SYSTEM HAD 2 FIBERTAKS PULL OUT. THIS OCCURRED DURING AN UNKNOWN PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 01/05/2022: THE PROCEDURE BEING PERFORMED WAS AN ECLIPSE. THE DEVICE PULLED OUT OF THE BONE. THE DEVICE DID NOT BREAK INSIDE OF THE PATIENT. THE BONE QUALITY OF THE PATIENT WAS POOR TO AVERAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484581 ↗
• MalfunctionMay 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 02/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9400-SBK IMPLANT SYSTEM ANCHOR WOULD NOT SEAT AND EVERY SINGLE ONE PULLED OUT OF IMPLANTATION SITE. SURGEON COMPLETED CASE USING A LARGER SWIVELOCK. NOTHING BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ECLIPSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398240 ↗
• MalfunctionMay 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 09/20/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TOWARD THE END OF THE CASE, ONLY 3 OF THE 5 ANCHORS IN THE AR-9400-SBK SPEEDSCAP IMPLANT SYSTEM, WERE USED AS TWO SWIVEL LOCKS PULLED OUT. THE REMAINING ANCHORS WERE LEFT IN THE PATIENT AS THEY REMAINED WHOLE AND SECURE. THIS WAS DISCOVERED DURING A TOTAL SHOULDER ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING ARTHREX 4.75 SWIVEL LOCKS WITH NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 19382112 ↗
• MalfunctionApr 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 1/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE THREE FIBERTAKS FROM AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM, PULLED OUT OF IMPLANTATION SITE. THE CASE WAS COMPLETED SUCCESSFULLY USING THE SWIVELOCKS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 1/5/2023: THE SWIVELOCKS THAT WERE USED TO COMPLETE THE CASE WERE NOT PART OF THE KIT, BUT INSTEAD SURGEON USED INDIVIDUAL AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING A SHOULDER HEMI ARTHROPLASTY PROCEDURE. NOTHING BROKE INSIDE THE PATIENT AND ALL THE FIBERTAKS THAT PULLED OUT, WERE FULLY REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 19202772 ↗
• MalfunctionApr 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ANCHORS WOULD NOT STAY SECURE IN THE BONE; THEY WOULD PULL OUT WHEN TENSIONED ON. THEY USED ANOTHER SWIVELOCK TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19137717 ↗
• MalfunctionJan 29, 2024Break; Break

  ON 01/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ANCHOR FROM AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM BROKE DURING INSERTION. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594604 ↗
• MalfunctionDec 5, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 11/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM HAD AN ISSUE. THE 3.9 MM SWIVELOCK INSERTER BENT UPON INSERTION. THE INSERTER DID NOT BREAK, BUT THE SCREW WAS UNUSABLE. THE CASE WAS COMPLETED USING ANOTHER AR-9400-SBK FROM A DIFFERENT LOT WITH A DELAY OF A MINUTE AND NO FRAGMENTS LEFT INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A TOTAL SHOULDER JOINT REPAIR PROCEDURE ON (B)(6) 2023, WITH NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271068 ↗
• InjuryFeb 9, 2023Positioning Failure; Positioning Problem; Positioning Failure

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT WHILE USING AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE, AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM AND AN AR-9301-51CPC ECLIPSE TRUNION, DURING THE FINAL STEPS, THE SURGEON DRILLED THE PILOT HOLE INTO THE SCREW AND FIXATION WAS COMPROMISED. SURGEON MOVED TO AN APEX SYSTEM INSTEAD. WHILE USING THE APEX, FIXATION WAS ALSO COMPROMISED WHEN TRAILING THE HEAD, SO SURGEON USED A LARGER SIZE INSTEAD.

  Patient problems: Insufficient Information

  MAUDE report 16341360 ↗
• MalfunctionJan 23, 2023Break

  ON 1/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT WHILE USING A SWIVELOCK FROM AN ECLIPSE SPEEDSCAP IMPLANT SYSTEM, IT BROKE. AN AR-2326BCC BIOCOMPOSITE SWIVELOCK WAS OPENED AND WHILE PASSING THE SUTURE THROUGH THE EYELET, IT SNAPPED OFF. ANOTHER AR-2326BCC BIOCOMPOSITE SWIVELOCK WAS OPENED, AND THE SAME THING HAPPENED, THE EYELET SNAPPED OFF WHILE PASSING THE SUTURE THROUGH IT. THIS WAS DISCOVERED DURING AN TSA PROCEDURE ON (B)(6) 2023. NEITHER ANCHOR WAS IMPLANTED, AS THIS WAS ALL OUTSIDE OF THE PATIENT, PRIOR TO IMPLANTATION. CASE WAS COMPLETED USING A 4.75 MM SWIVELOCK. ADDITIONAL INFORMATION RECEIVED ON 1/5/2023: THE SWIVELOCK FROM THE ECLIPSE SPEEDSCAP IMPLANT SYSTEM, PART NUMBER AR-9400-SBK, HAD THE EYELET BREAK OFF INSIDE THE PATIENT DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING AR-2324BCC BIOCOMPOSITE SWIVELOCKS.

  Patient problems: Insufficient Information

  MAUDE report 16223347 ↗
• InjuryNov 8, 2021Device Dislodged or Dislocated

  THE SURGEON INSERTED 2 OF THE AR-9400SBK SPEEDSCAP 3.9 IMPLANTS INTO THE HUMERUS, BOTH PULLED OUT OF THE BONE. THE CASE WAS COMPLETED USING A 5.5 SWIVELOCK AND A 4.75 SWIVELOCK(TECHNIQUE CHANGE).

  Patient problems: Failure of Implant

  MAUDE report 12770405 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED TWO OF THE FIBERTAK ANCHORS WITHIN THE AR-9400-SBK SNAPPED WHEN PULLING THROUGH THE SUBSCAP. ANOTHER KIT WAS OPENED FOR TWO MORE ANCHORS AND THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872488 ↗