Arthrex® AR-6068CRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867038981), received between Aug 29, 2016 and Jun 14, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 14, 2024Failure to Advance; Failure to Advance

  ON 04/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6068C QUICKPASS LASSOS WIRE IS UNABLE TO GO THROUGH AND IS NOT CATCHING THROUGH THE WHEEL. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19541097 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 05/07/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6068C QUICKPASS LASSO BROKE OFF INSIDE THE JOINT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS REMOVED. ADDITIONAL INFORMATION REQUESTED ON 5/10/24

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460905 ↗
• MalfunctionMay 6, 2022Break; Material Twisted/Bent

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT DURING A LABRUM REPAIR, THE SURGEON WAS ATTEMPTING TO PASS A AR-4068-25TRF SUTURE LASSO THROUGH CAPSULE/ANTERIOR LABRUM IT BENT AND THE TIP OF TWO AR-6068C SUTURE LASSOS BROKE ALONG WITH A AR-13995N SCORPION NEEDLE. THE SURGEON COMPLETED THE CASE WITH A NEW SCORPION NEEDLE TO PASS SUTURES, AND THE BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 14310313 ↗
• MalfunctionMay 6, 2022Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT DURING A LABRUM REPAIR, THE SURGEON WAS ATTEMPTING TO PASS A AR-4068-25TRF SUTURE LASSO THROUGH CAPSULE/ANTERIOR LABRUM IT BENT AND THE TIP OF TWO AR-6068C SUTURE LASSOS BROKE ALONG WITH A AR-13995N SCORPION NEEDLE. THE SURGEON COMPLETED THE CASE WITH A NEW SCORPION NEEDLE TO PASS SUTURES, AND THE BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 14309930 ↗
• MalfunctionMar 21, 2022Break

  ON 03/02/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6068C CRESCENT, QUICKPASS LASSO HAD AN ISSUE, THE TIP PULLED OFF IN THE CASE, AND WAS REMOVED SAFELY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON 03/16/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING CASE INFORMATION VIA EMAIL AND OVER THE PHONE FOR ADDITIONAL CLARIFICATION: THIS EVENT OCCURRED DURING A LABRUM REPAIR. WHEN THE SURGEON USED THE COMPLAINT DEVICE, THE METAL TIP BROKE OFF AND WAS EMBEDDED IN THE LABRUM. IT TOOK A WHILE TO FIND THE TIP. IN ORDER TO REMOVE IT, THEY SHAVED TISSUE AWAY AND USED SUCTION TO PLACE IT IN REACH OF THE GRASPER. ONCE THEY ACCOMPLISHED THAT, THEY SWITCHED TO A DIFFERENT QUICKPASS LASSO (PART AND LOT NUMBER UNKNOWN) TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PROCEDURE WAS DELAYED BY 15 MINUTES, NO ADDITIONAL ANESTHESIA WAS REQUIRED AND THERE WAS NO HARM TO THE PATIENT SINCE THEY WERE ABLE TO REMOVE IT. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839724 ↗
• MalfunctionSep 17, 2020Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE TIP OF THE DEVICE SNAPPED OFF AND BECAME LOOSE IN THE PATIENT. THE LOOSE PART WAS RETRIEVED FROM THE PATIENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED USING A RHINO PASSER. SURGERY PERFORMED WAS A SHOULDER STABILIZATION SURGERY. UPDATE 03-SEP-2020: INFORMATION RECEIVED TODAY THAT SURGEON HAD TO SWITCH TO AN OPEN PROCEDURE TO REMOVE THE BROKEN TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10546242 ↗
• InjuryAug 29, 2016Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR, THE TIP OF THE CRESCENT, QUICKPASS LASSO BROKE-OFF IN THE SOFT TISSUE OF THE SHOULDER JOINT. PER THE SURGEON THE BROKEN PIECE WAS SECURE SO IT WAS NOT REMOVED. THE PATIENT WAS RELEASED FROM SURGERY CENTER PER FACILITY PROTOCOL. PATIENT WAS A (B)(6) FEMALE, DOB (B)(6).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5911982 ↗