Arthrex® AR-9207SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867137493), received between Mar 19, 2019 and Aug 29, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANATOMICAL SHOULDER RECONSTRUCTION SURGERY THE PIN BROKE OFF DUE TO LEVERAGE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925390 ↗
• MalfunctionSep 4, 2024Break; Break

  ON 08/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9207S PIN SETS PIN SNAPPED. THIS OCCURRED DURING USE, THERE WAS NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135271 ↗
• MalfunctionJun 19, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE AR-9401-13 ECLIPSE EXTRAMEDULLARY GUIDE WAS COMPROMISED DURING A PROCEDURE. WHILE ATTEMPTING TO USE THIS GUIDE WITH THE ACCOMMODATING 2.8MM ECLIPSE DRILL PIN, THE GUIDE WOULD NOT ADVANCE ADEQUATELY. AFTER REDIRECTING STEPS AND TRYING TO REMOVE THE PIN FROM THE GUIDE VIA POWER IT COLD WELDED WITH THE INNER CANNULATION. THE SURGEON WAS ABLE TO REMOVE THE PIN AND GUIDE AND PROGRESSED TO THE NEXT STEPS OF THE HUMERAL HEAD CUT. THERE WAS A DELAY OF ABOUT FIVE MINUTES. THE PIN WAS ABLE TO BE REMOVED FROM THE GUIDE AND BOTH WERE RECOVERED. THE PROCEEDING STEPS WERE NOT COMPROMISED, AND THERE WERE NO UNPLANNED INCISIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566267 ↗
• MalfunctionJun 19, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE AR-9207S 2.8 PINS ARE TOO BIG AND BECOME STUCK IN THE AR-9401-13 RESECTION GUIDE. THE CASE WAS COMPLETED SAFELY WITHOUT THE GUIDE. SEE ATTACHED IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565921 ↗
• MalfunctionJun 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  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 19563524 ↗
• MalfunctionMay 6, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY THE SALES REP THAT THE 2.8 STEINMANN PIN WAS TOO BIG TO FIT THROUGH THE GLENOID GUIDE DURING A TOTAL SHOULDER ARTHROPLASTY. THE CASE WAS COMPLETE BY USING A NEW AR -9207S.

  Patient problems: Insufficient Information

  MAUDE report 19249007 ↗
• MalfunctionApr 30, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE 2.8 GUIDE PIN DOES NOT FIT THROUGH THE GUIDES FOR THE VAULT LOCK. THEY HAD TO OPEN AR-9607S FOR THE REVERSE 2.8 GUIDE PIN. THE REVERSE 2.8 FITS WHILE THE ECLIPSE 2.8 DOES NOT.

  Patient problems: Insufficient Information

  MAUDE report 19212434 ↗
• MalfunctionApr 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE 2.8MM PIN FROM THE AR-9207S, SET IS OVERSIZED , SO THE CORRESPONDING REAMERS (AR-9126RP AND AR-9126RC) WOULD NOT PROPERLY SLIDE DOWN THE PIN. ADDITIONAL INFORMATION 3/23/2021 IT WAS REPORTED THAT DURING A RTSA PROCEDURE, THE 2.8MM PIN FROM THE AR-9207S, SET IS OVERSIZED, SO THE CORRESPONDING REAMERS (AR-9126RP AND AR-9126RC) WOULD NOT PROPERLY SLIDE DOWN THE PIN. THE CASE WAS COMPLETED BY USING A 2.4 GUIDE PIN THROUGH THE PRIMARY POST REAMER.

  Patient problems: Insufficient Information

  MAUDE report 19185841 ↗
• MalfunctionApr 24, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED DURING A SHOULDER CASE THE PIN WAS STUCK INSIDE THE CUT GUIDE. WHEN THE GUIDE WAS REMOVED THE PIN CAME OUT. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173330 ↗
• MalfunctionApr 24, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE 2.8 STEINMAN PIN FROM THE AR-9207S UNIVERS II / ECLIPSE PIN KIT WOULD NOT FIT THROUGH THE VAULTLOCK GUIDES. THE SURGEON TRIED ON POWER AND HAND. IN ADDITION, THE REP REMOVED THE PIN AND GUIDE FROM THE STERILE FIELD AND TRIED; BUT IT WAS PHYSICALLY IMPOSSIBLE TO FIT THE 2.8 PIN THROUGH. THE CASE WAS COMPLETED BY OPENING AN AR-9507S FOR THE 2.4 GUIDE PIN. SEE SOURCE DATA AND IMAGES ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172925 ↗
• MalfunctionApr 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED DURING A PROCEDURE, THE 2.8MM PIN WITHIN AR-9207S BECAME COLD WELDED INTO RESECTION GUIDE AR-9401-13. IT WAS REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. SEE PHOTO ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134670 ↗
• InjuryFeb 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/9/2024, IT WAS REPORTED ON CASE NUMBER (B)(4) BY A SALES REPRESENTATIVE VIA (B)(4) THAT A REVISION REVERSE TSA PROCEDURE OCCURRED ON (B)(6) 2024 FOR UNKNOWN REASONS. DURING THE PROCEDURE, IT WAS REPORTED THAT AN AR-9545-T15-01 DRIVER SHAFT WAS STRIPPED WHEN TRYING TO REMOVE SCREWS FROM THE MGS BASEPLATE. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED PATIENT HARM AND NO FURTHER INFORMATION PROVIDED. NO PIECES BROKE INSIDE THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON WHAT CAUSED THE NECESSARY REVISION SURGERY ON (B)(6) 2024 ON (B)(4) FOR CASE NUMBER (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON 1/31/2024: ON 1/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A PATIENT HAD UNDERGONE A REVISION REVERSE TSA PROCEDURE ON (B)(6) 2024 DUE TO AN INFECTION. ALL COMPONENTS HAD TO BE REMOVED, AND THE SUTURE CUP HAD TO BE SEPARATED FROM THE STEM FOR EXPLANTATION. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2023 AT THE SAME FACILITY. NO NEW PRODUCTS WERE IMPLANTED AFTER EXPLANTATION. THE CASE WAS COMPLETED USING ANOTHER AR-9545-T15-01 DRIVER SHAFT TO REMOVE THE SUTURE CUP. THE SURGEON STATED THE PATIENT'S CURRENT HEALTH STATUS HAD BEEN REPORTED AS G

  Patient problems: Unspecified Infection

  MAUDE report 18622735 ↗
• InjuryMar 19, 2019Break

  IT WAS REPORTER VIA FDA MEDWATCH LETTER (MW5083334) THAT DURING A PROCEDURE ON (B)(6) 2018, "A GUIDEWIRE WAS INSERTED INTO THE SCAPULA AND IN THE PROCESS IT BROKE OFF WITHIN THE BODY OF THE SCAPULA. MEDIAL PORTION OF THE GUIDE PIN WAS ENCASED IN THE CORTICAL BONE. NUMEROUS ATTEMPTS WERE MADE TO RETRIEVE THE RETAINED PORTION OF THE GUIDEWIRE BUT ULTIMATELY THE DECISION WAS MADE TO LEAVE IT THE BONE." NO PART NUMBER WAS PROVIDED IN THE LETTER HOWEVER THE LOT NUMBER PROVIDED MATCHES IN THE ARTHREX SYSTEM TO PART AR-9207S, PIN SET UNIVERS II/ECLIPSE. THE ABOVE EVENT DESCRIPTION WAS ENTERED BY ARTHREX AS RECEIVED IN THE MEDWATCH REPORT. THIS EVENT DESCRIPTION MAY CONTAIN CLAIMS OR LANGUAGE FROM THE REPORTER/COMPLAINANT REGARDING ARTHREX DEVICE PERFORMANCE. SUCH CLAIMS HAVE NOT BEEN EVALUATED BY ANY ARTHREX PRODUCT EXPERTS. ARTHREX¿S INCLUSION OF ANY CLAIMS SHOULD NOT BE CONSTRUED AS ARTHREX EXPRESSING AGREEMENT WITH SUCH CLAIMS. THIS COMPLAINT WILL BE EVALUATED AS ALL COMPLAINTS ARE IN ACCORDANCE WITH ARTHREX COMPLAINT HANDLING PROCEDURES. ADDITIONAL INFORMATION OBTAINED 3/19/19: THE SALES REP HAS CONFIRMED THAT THE PART NUMBER INVOLVED WAS AR-9207S.

  Patient problems: Foreign Body In Patient

  MAUDE report 8432730 ↗