Arthrex® AR-1996CD-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867025714), received between Jan 31, 2024 and Aug 21, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Adverse Event Without Identified Device or Use Problem

  On 06 August 2026, it was reported by a Sales Representative via email that an AR-4030C-09, 9X 30MM BC IF SCRW VENTED was reported to be broken. Dr was inserting the interference screw AR-4030C-09 Lot 15231892 with the screwdriver from our tray and the screw broke. This occurred on (b)(6) 2026 during an unknown Procedure.

  Patient problems: Insufficient Information

  MAUDE report 50379946 ↗
• MalfunctionJan 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12/9/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1996CD-1 BIOCOMPOSITE INTERFERENCE SCREW DRIVER HAD BIOBURDEN STUCK IN THE CANNULATION AND COULD NOT TIGHTEN AN AR-4030C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/19/2024: THIS WAS DISCOVERED WHEN THE GUIDEWIRE WAS ATTEMPTED TO BE INSERTED IN THE AR-1996CD-1 BIOCOMPOSITE INTERFERENCE SCREW, IT WAS NOTICED THE DRIVER HAD BIOBURDEN STUCK IN THE CANNULATION. THE PROCEDURE PERFORMED WAS AN ACLR. THE CASE WAS COMPLETED USING A SCREW FROM ANOTHER MANUFACTURER, AS THERE WERE NO OTHER DRIVERS AVAILABLE. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADMINISTERING ADDITIONAL ANESTHESIA.

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

  MAUDE report 21071825 ↗
• MalfunctionJun 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE SCREW DRIVER BECAME STUCK IN THE SCREW AR-4020C-08 AND IT DID NOT COME OFF. THEY SURGEON HAD TO BREAK THE SCREW, EVEN SAW IT OFF OUTSIDE THE PATIE BECAUSE IT DID NOT COME OFF. 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 19564131 ↗
• MalfunctionJan 31, 2024Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION WAS RECEIVED ON 2/9/2024: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE. WHEN THE SURGEON WENT TO LOAD THE AR-1996CD-1 DRIVER ONTO THE NITNOL WIRE, IT WOULD NOT ADVANCE. THE DRIVER HAD NEVER BEEN USED BEFORE. THEY OPENED ANOTHER NEW SET AND TRIED A DIFFERENT AR-1996CD-1, AND IT WENT UP THE NITNOL WIRE WITH NO ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 2/12/2024: PER THE AGENCY MANAGER: "I DID TRY TO RUN NUMEROUS WIRES FRONT TO BACK ON BOTH DRIVERS. THE NEW DRIVER WE TRIED TO USE INTEROPERATIVE WAS ALSO HANDLED BY BOTH THE SCRUB TECH AND DR MOSER. THEY WERE AT THE STAGE OF NEEDING A SCREW SO THEY WERE BOTH DETERMINED TO FIGURE OUT HOW TO GET THAT DRIVER UP THE NITNOL WIRE. I HAD SPD KEEP THE DRIVER OUT OF THE SET SO I COULD MESS WITH IT MYSELF AND I TRIED RUNNING MULTIPLE NITNOL WIRES FROM THE BACK AND THROUGH THE DRIVER TIP. WHEN THE REPLACEMENT DRIVER CAME IN I DID THE SAME WHICH IS WHY I TOOK A PICTURE OF THE DRIVERS SO YOU COULD SEE. IT'S A TINY HOLE TO LOOK DOWN BUT I SUSPECT THERE IS A METAL EDGE THAT MAY BE BLOCKING THE WIRES WITHIN THOSE DRIVERS. IT'S THE ONLY THING THAT MAKES SENSE. THEY WERE BOTH TAKEN DIRECTLY OUT OF THE PACKAGES BRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614178 ↗