Arthrex® AR-8692DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867190986), received between Jan 23, 2018 and Nov 26, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PLANTAR PLATE REPAIR SURGERY THE LEADING SHAFT BECAME BENT. 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 23657917 ↗
• MalfunctionMay 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 18 APRIL 2024, IT WAS REPORTED BY FIELD STAFF VIA EMAIL THAT THERE HAD BEEN AN INCIDENT WITH AN AR-8692DS 4 IMPLANT SYSTEM, CPR VIPER. ON (B)(6) 2024 IN SOUTHERN CROSS CHRISTCHURCH HOSPITAL, THE SURGEON USED THE CPR VIPER FOR A FIRST PASS OF SUTURE IN A 2ND RAY PLANTAR PLATE REPAIR. WHEN THE NEEDLE HAD PASSED THROUGH THE END OF THE CPR VIPER IT GOT CAUGHT AND WOULD NOT RETRACT. THE CASE WAS COMPLETED SUCCESSFULLY THROUGH THE USE OF ANOTHER CPR VIPER. THERE WAS CASE/PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19311942 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A PLANTAR PLATE REPAIR SURGERY THE TIP OF THE INSTRUMENT BROKE OFF. IT WAS FURTHER REPORTED THAT NO FORCE WAS APPLIED AND THE DEVICE WAS USED CORRECTLY. THE BROKEN PIECES WAS RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19279404 ↗
• MalfunctionApr 29, 2024Use of Device Problem; Use of Device Problem

  ON 12/03/2021, IT WAS REPORTED BY ARTHREX EMPLOYEE VIA SEMS THAT A AR-8692DS IMPLANT SYSTEM WAS UNABLE TO RETRIEVE SUTURES WITH MULTIPLE ATTEMPTS TRIED THERE WAS NO SUCCESS. THIS OCCURRED DURING AN UNKNOWN PROCEDURE, AND BOTH THE REPRESENTATIVE AND THE SURGEON ATTEMPTED BOTH DURING AND AFTER THE OPERATION. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201693 ↗
• MalfunctionMar 1, 2024Break; Break

  ON 02/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8692DS CPR VIPER SUTURE TAPE HOOK BROKE OFF WHEN TRYING TO GET UNDERNEATH PLANTAR PLATE. ALL FRAGMENTS REMOVED. NO DELAY TO CASE. PROCEDURE COMPLETED USING SPARE VIPER KIT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817155 ↗
• MalfunctionJan 3, 2024Failure to Advance; Failure to Advance

  ON 12/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE VIPER FROM AN AR-8692DS CPR VIPER IMPLANT SYSTEM WOULD NOT DEPLOY. THIS WAS DISCOVERED DURING A PLANTAR PLATE REPAIR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER AR-8692DS CPR VIPER IMPLANT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 18437340 ↗
• InjuryJan 23, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON HIS RIGHT FOOT ON (B)(6) 2017 WHERE A 4MM PROXIMAL WEDGE PLATE (LINE: (B)(4)) AND A 3.5MM HEADLESS SCREW FOR CHEVRON (LINE: (B)(4)) WERE IMPLANTED. ALSO IMPLANTED WAS A 2.4 HEADED SCREW FOR K-WIRE BUT REPORTER DOES NOT BELIEVE THIS IS AN ARTHREX PRODUCT. THE PATIENT BEGAN TO EXPERIENCE HEAT AND SWELLING IN HIS FOOT ABOUT 2 MONTHS POST-OP. THE SURGEON IS CONSIDERING REMOVING THE HARDWARE. PATIENT'S ONLY KNOWN DRUG ALLERGY IS TO NEOMYECIN ANTIBIOTIC OINTMENT. FOLLOW-UP INVESTIGATION: DATE OF SURGERY WAS (B)(6) 2017, PATIENT IS A MALE, SURGERY WAS ON RIGHT FOOT. PATIENT HAS SIGNIFICANT SWELLING TO DATE, 4.5 MONTHS AFTER SURGERY. DECISION TO REMOVE THE HARDWARE HAS NOT BEEN MADE. PATIENT IS STILL EXPERIENCING THE LOCALIZED HEAT AND SWELLING AT THE SURGICAL SITE. PART NUMBERS HAVE NOW BEEN OBTAINED AND THE MATERIAL COMPOSITION OF EACH IMPLANT HAS BEEN PROVIDED.

  Patient problems: Swelling

  MAUDE report 7211695 ↗