Arthrex® AR-13930DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867015715), received between Jan 13, 2020 and Feb 3, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Break

  ON 08-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13930DS VIPER SUTURE BROKE WHEN THE NEEDLE WAS INSERTED INTO THE MENISCUS. THE SURGERY WAS COMPLETED USING A NEW PRODUCT OF THE SAME PART NUMBER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245592 ↗
• MalfunctionJul 31, 2025Material Frayed; Material Frayed

  ON 07/09/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13930DS MENISCAL VIPER THREAD WAS FRAYED WHEN IT WAS RETRIEVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675442 ↗
• MalfunctionJul 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON 06/13/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-13930DS MENISCL VIPER REPR KIT INNER CYLINDER CAME OFF WHEN THE REMOVING THE PRODUCT FROM THE JOINT. 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 22456063 ↗
• MalfunctionJun 10, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON 04/24/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-13930DS MENISCAL VIPER REPAIR DISPOSABLE KIT HAD RESISTANCE WHEN PUSHING THE NEEDLE OUT, AND IT DID NOT CATCH THE THREAD WELL. THE THREAD BROKE THREE TIMES WHEN TRYING TO FORCEFULLY PULL IT OUT. THE CASE WAS COMPLETED WITH ANOTHER AR-13930DS MENISCAL VIPER REPAIR DISPOSABLE KIT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 5/19/2025: THIS ISSUE OCCURRED IN THE PATIENT DURING A MENISCUS REPAIR PROCEDURE, AND ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176621 ↗
• MalfunctionMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 05/08/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13930DS MENISCAL VIPER NEEDLE PULLED OUT AFTER BEING INSERTED IN THE MENISCUS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091826 ↗
• MalfunctionJul 8, 2024Break; Break

  ON 6/11/2024, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA SEMS-(B)(4) THAT AN AR-13930DS MENISCAL VIPER REPAIR DISPOSABLE KIT HAD A SIGNIFICANTLY DIFFERENT RESISTANCE THAN USUAL, WHICH WAS NOTICED BY FEEL. THEY TRIED TO USE THE DEVICE, BUT THE SUTURE BROKE. THE CASE WAS COMPLETED BY USING A NON-ARTHREX PRODUCT. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 6/20/2024: THE BROKEN SUTURE WAS REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING A MENISCAL REPAIR ON (B)(6) 2024. NO CASE DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689093 ↗
• MalfunctionMay 4, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-13930DS MENISCAL VIPER TIP BROKE OFF DURING INSERTION. THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING A NEW AR-13930DS MENISCAL VIPER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: THIS WAS DISCOVERED DURING A MENISCUS REPAIR PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869421 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS PROVIDED THE FOLLOWING INFORMATION: PATIENT HAD UNDERGONE A LEFT FOOT OSTEOTOMY METATARSAL/ LEFT WEIL PLANTAR PLATE REPAIR ON (B)(6) 2017. DURING THE PROCEDURE, AN ARTHREX ACP INJECTION SYSTEM (ACP KIT SERIES II, ABS-10012, LOT 616565204, QTY 2) WAS UTILIZED AND 2 ARTHREX QUICK FIX SCREWS WERE IMPLANTED (AR-8930-11, LOT 10111019). THE FOLLOWING ARTHREX PRODUCTS WERE ALSO USE: AR-13930DS (LOT 703771055) MENISCAL VIPER REPAIR KIT AND AR-8690DS (LOT 10091584, QTY 2) IMPLANT SYSTEM, CPR MINI SCORPION DX. AFTER THE LOCAL ANESTHETIC WORE OFF HIS LEFT FOOT FELT LIKE IT WAS ASLEEP AND THE FEELING RADIATED TO JUST ABOVE THE ANKLE BONE. FEELING HAS NOT GONE AWAY SINCE THE SURGERY. CONDITION DOES NOT IMPACT ANY ACTIVITY, EXCEPT IT FEELS STRANGE, OFTEN A DEAD FEELING AND COLD. ONLY EXCEPTION TO FUNCTIONALITY IS PATIENT'S BALANCE WHILE STANDING ON HIS LEFT FOOT ONLY IS SLIGHTLY WORSE THAN THEN STANDING ON HIS RIGHT FOOT. PATIENT HAD REACHED OUT TO THE SURGEON IN EARLY 2019 BUT CHOSE TO FOLLOW UP WITH HIS LOCAL PHYSICIAN WHO REFERRED HIM FOR REVIEW BY A NEUROLOGIST. EMG EXAM WAS CONDUCTED AND MRI'S WERE PERFORMED ON THE LEFT KNEE AND ANKLE. PATIENT RECAP OF TESTING RESULTS: EMG S

  Patient problems: Edema; Nerve Damage

  MAUDE report 9580147 ↗