Arthrex® AR-3371-4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867030145), received between Jul 20, 2016 and Sep 23, 2024 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Naturally Worn; Naturally Worn

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3371-4000 SHEATH BODY¿S END LOOKS BEAT UP AND IS CATCHING SOFT TISSUE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278135 ↗
• MalfunctionAug 12, 2024Break; Break

  ON 07/15/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-3371-4000 SHEATH BODY'S TROCAR IS BROKEN. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19960957 ↗
• MalfunctionJun 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE TIP OF THE SHEATH IS BENT AND THE SCOPE CANNOT GO THROUGH IT.

  Patient problems: Insufficient Information

  MAUDE report 19514313 ↗
• MalfunctionMay 22, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SHEATH IS BENT.

  Patient problems: Insufficient Information

  MAUDE report 19372494 ↗
• MalfunctionDec 15, 2023Device Damaged Prior to Use; Defective Device; Device Damaged Prior to Use; Defective Device

  ON 11/16/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3371-4000 SHEATH BODY WAS DAMAGED IN AN UNSPECIFIED STATE WITH NO FURTHER INFORMATION PROVIDED. IT IS STATED THAT IT IS UNKNOWN IF THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18340868 ↗
• MalfunctionJul 25, 2022Break

  ON 7/5/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA MEDWATCH EMAIL THAT THE TIP OF AN AR-3371-4000 ARTHROSCOPE SHEATH BROKE OFF INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED. THIS WAS DISCOVERED DURING A SHOULDER JOINT FRACTURE PROCEDURE ON (B)(6)2022. NO FURTHER INFORMATION HAS BEEN GIVEN.

  Patient problems: Insufficient Information

  MAUDE report 15092747 ↗
• MalfunctionJul 11, 2022Break

  ON 6/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3370-4000 SHEATH BODY TIP CAME OFF DURING A PROCEDURE. SURGEON WAS ABLE TO REMOVE ALL THE BROKEN PIECES AND COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976425 ↗
• MalfunctionMar 8, 2021Leak/Splash

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE SURGEON NOTICED THAT THE SHEATH, AR-3371-4000 WAS LEAKING WATER. THE CASE WAS COMPLETED BY USING ANOTHER SHEATH WITHOUT FURTHER ISSUE. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: Insufficient Information

  MAUDE report 11436911 ↗
• InjuryFeb 19, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT SEVEN MONTHS POST-OP, THE PATIENT REPORTED PAIN IN HIS KNEE; AN X-RAY SHOWS THAT THE TIP OF THE AR-3371-4000 SHEATH BODY WAS IN THE PATIENT. THE ORIGINAL DATE OF THE KNEE SCOPE SURGERY WAS (B)(6) 2018. THERE WILL BE A FOLLOW UP SURGERY TO REMOVE THE TIP ON (B)(6) 2019. ADDITIONAL INFORMATION OBTAINED (B)(6) 2019: THE SECOND SURGERY TO REMOVE THE UN-RETRIEVED FRAGMENT WAS PERFORMED ON (B)(6) 2019. IT WAS PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON. THERE WAS NO NOTATION MADE AT THE TIME OF THE ORIGINAL PROCEDURE THAT A PIECE WAS MISSING FROM THE SCOPE SHEATH USED DURING THE PROCEDURE. AT TIME OF X-RAY, WHEN THE FRAGMENT WAS DISCOVERED, IT WAS THE SURGEON WHO DETERMINED THAT THE FRAGMENT WAS A PIECE OF THE AR-3371-4000 SCOPE SHEATH. AT THIS TIME THE RISK MANAGER WILL NOT RELEASE THE SCOPE SHEATH OR EXPLANTED FRAGMENT FOR EVALUATION BY ARTHREX.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 8350761 ↗
• InjuryJul 20, 2016Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE DISTAL END OF THE SHEATH BROKE OFF DURING A SURGERY INSIDE OF THE PATIENT'S BODY. SURGERY PERFORMED WAS A KNEE ARTHROSCOPY. FRAGMENT WAS RETRIEVED FROM THE PATIENT'S BODY, SURGERY WAS FINISHED SUCCESSFULLY. THE PIECE BROKE-OFF IN THE FATTY TISSUE OF THE PATIENT - THE FATTY TISSUE WAS RESECTED WITH A SHAVER AND UNDER X-RAY IMAGING IT WAS RETRIEVED.

  Patient problems: Tissue Damage

  MAUDE report 5808041 ↗