Arthrex® AR-6068-25RRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867247512), received between Jul 19, 2017 and Mar 13, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Material Frayed; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SUTURE GUIDE WHEEL JAMMED, MAKING SUTURING VERY DIFFICULT WITH THE SUTURE FRAYING. NO OTHER DEVICE WAS AVAILABLE, AND DESPITE NUMEROUS ATTEMPTS, IT WAS IMPOSSIBLE TO THREAD A SECOND SUTURE THROUGH THE DEVICE. THIS RESULTED IN AN HOUR'S DELAY IN THE PROCEDURE AND ANESTHESIA FOR THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 24597115 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A QUICKPASS SURGERY THE HOOK BROKE. THE PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 21138258 ↗
• MalfunctionOct 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MENISCAL RAMP LEASION SURGERY THE SUTURE DID NOT COME OUT OF THE QUICKPASS SUTURE LASSO AS IF IT WAS CUT ON BOTH SIDES. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (KNEE SCORPION AND FIBERWIRE). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427259 ↗
• MalfunctionSep 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ACL REPAIR SURGERY THE WIRE WINDED IN THE ROLLERS AND DID NOT CAME OUT OF THE END.. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 20124989 ↗
• MalfunctionJun 24, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE THREAD DID NOT CLIMB INTO THE HOOK FROM THE FIRST USE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 19598453 ↗
• MalfunctionMay 26, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SEWING THE MENISCUS THE SUTURE INSIDE THE LASSO COULD NOT BE RELEASED BECAUSE IT WAS CAUGHT ON THE WHEEL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 19398848 ↗
• MalfunctionFeb 26, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SUTURE GOT CAUGHT IN THE WHEEL AND WRAPPED COMPLETELY AROUND IT. A NEW SUTURE WAS USED, BUT THE SAME SITUATION OCCURRED: THE SUTURE WAS BLOCKED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 18782365 ↗
• MalfunctionFeb 26, 2024Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SUTURE GOT CAUGHT IN THE WHEEL AND WRAPPED COMPLETELY AROUND IT. A NEW SUTURE WAS USED, BUT THE SAME SITUATION OCCURRED: THE SUTURE WAS BLOCKED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 18780947 ↗
• MalfunctionJan 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE SURGERY IT WAS IMPOSSIBLE TO RELOAD A WIRE INTO THE QUICKLASSO. 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 18566265 ↗
• MalfunctionDec 29, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE WIRE DID NOT GO THROUGH THE CANNULA. 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 18419686 ↗
• MalfunctionDec 26, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE WIRE DID NOT GO THROUGH THE CANNULA. 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 18394269 ↗
• MalfunctionNov 17, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) AND RAMP LESION SURGERY THE SURGEON USED THE SUTURE LASSO FOR THE RAMP REPAIR. DURING THE CASE THEY USED FOUR SUTURE LASSO BECAUSE THE SUTURE DIDN¿T GET OUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 18160261 ↗
• MalfunctionNov 10, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) AND RAMP LESION SURGERY THE SURGEON USED THE SUTURE LASSO FOR THE RAMP REPAIR. DURING THE CASE THEY USED FOUR SUTURE LASSO BECAUSE THE SUTURE DIDN¿T GET OUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 18111390 ↗
• MalfunctionNov 7, 2023Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RAMP SUTURE SURGERY THE QUICKLASSO ARE OBSTRUCTED AND ANY SUTURE CANNOT GO OUT OF OUR DEVICE. 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 18085552 ↗
• MalfunctionNov 7, 2023Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RAMP SUTURE SURGERY THE QUICKLASSO ARE OBSTRUCTED AND ANY SUTURE CANNOT GO OUT OF OUR DEVICE. 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 18085501 ↗
• MalfunctionFeb 13, 2023Defective Device; Physical Resistance/Sticking; Physical Resistance/Sticking

  26-APR-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT AR-6068-25L LOT 2228124440 WAS USED INSTEAD OF TWO WITH THE LOT 0287107073.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361856 ↗
• MalfunctionFeb 13, 2023Output Problem; Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SURGEON WAS NOT ABLE TO UNWOUND THE THREAD. THE DEVICE IS BLOCKED ON 1CM OF THREAD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THAT DUE TO THE CHANGE OF THE DEVICE THE PROCESS NEEDED TO BE CHANGED. NO FURTHER INFORMATION WERE PROVIDED. 30-JAN-2023 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE SAME ISSUE OCCURRED MULTIPLE TIMES DURING ONE SURGERY WITH MULTIPLE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361808 ↗
• InjuryJul 19, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE SURGEON USED THE SUTURELASSO FOR THE RAMP LESION. DURING THE PROCEDURE THE TIP OF THE LASSO BROKE INSIDE THE PATIENT AND INTO THE SOFT TISSUE. IT TOOK 1.5 HOURS FOR THE SURGEON TO FIND AND REMOVE THE BROKEN TIP. TO FIND THE BROKEN TIP HE ALSO DID AN X-RAY. AFTER THAT HE CHANGED THE SURGICAL TECHNIQUE AND CLOSED THE RUPTURE IN THE NORMAL WAY WITH A NEEDLE AND A SUTURE. THE SURGERY WAS A KNEE MENISCUS SURGERY.

  Patient problems: No Information

  MAUDE report 6724217 ↗