Arthrex® AR-13996Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867015968), received between Feb 11, 2020 and Sep 3, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionSep 3, 2025Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  ON 08/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13996 SCORPION IS NOT CLOSING ALL THE WAY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954198 ↗
• InjuryJul 25, 2025Break; Break

  ON 11/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-13995N-1 MULTIFIRE SCORPION NEEDLE FRAGMENT WAS DISCOVERED IN THE PATIENT DURING A POSTOPERATIVE X-RAY. THE IMAGES SHOWED A SMALL PIECE OF METAL IN THE PATIENT'S SUBACROMIAL INTERVAL. THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE METAL FRAGMENTS REMOVED. ONCE REMOVED, THE METAL FRAGMENT FITS PERFECTLY WHEN PLACED ON THE TIP AREA OF THE MULTIFIRE SCORPION NEEDLE. THIS OCCURRED DURING A RIGHT SHOULDER ARTHROSCOPY RCR AND BICEP TENODESIS PROCEDURE IN (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 7/3/2025: AN AR-13996 MULTIFIRE SCORPION THAT WAS USED WITH THE BROKEN AR-13995N-1 MULTIFIRE SCORPION NEEDLE WAS RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22620708 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED, THAT DURING AN ACL PROCEDURE THE TOP JAW ON THE AR-13996, SCORPION CAME LOOSE. THE CASE WAS COMPLETED USING AR-13997MF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547081 ↗
• MalfunctionJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE IS DULL. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498375 ↗
• MalfunctionMay 20, 2024Break; Break

  ON 03/31/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-13996 SCORPIONS JAWS DO NOT ALIGN PROPERLY, AND WAS DECLARED UNUSABLE. THIS WAS DISCOVERED DURING AN UNKNOWN TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351089 ↗
• MalfunctionDec 27, 2022Break; Break; Retraction Problem; Mechanical Jam

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13996 SCORPION NEEDLE WAS GETTING STUCK AND WOULD NOT RETRACT BACK. CASE INVOLVEMENT, NO PATIENT EFFECT. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051317 ↗
• InjuryFeb 11, 2020Material Fragmentation

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE AS THE SURGEON WAS PASSING SUTURES THROUGH THE CUFF, THEY REALIZED THAT A PIECE OF THE JAW ON THE AR-13996 MULTIFIRE SCORPION WAS MISSING. THE SURGEON PROCEEDED TO LOOK FOR THE BROKEN FRAGMENT. AN X-RAY WAS CALLED AND CONFIRMED THE BROKEN PIECE WAS IN THE PATIENT'S SHOULDER. AFTER MANY ATTEMPTS, THE SURGEON DECIDED TO LEAVE THE PIECE DUE TO IT BEING FAR BACK WITH THE REPAIR. THE REP REPORTED NO UNPLANNED INCISIONS WERE MADE. THE PROCEDURE WAS THE FIRST CASE OF THE DAY, AND THE FACILITY USUALLY KEEPS TWO SCORPIONS IN THEIR TRAY. THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN. THE COMPLAINT DEVICE IS CURRENTLY BEING HELD BY THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. IT IS CURRENTLY UNKNOWN IF THE SURGEON PLANS TO PERFORM A SECOND SURGERY. ADDITIONAL INFORMATION RECEIVED ON 01/30/2020: THE REP RECEIVED CONFIRMATION FROM THE SURGEON THAT A SECOND SURGERY WILL NOT BE PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9695545 ↗