Arthrex® AR-6068-45LRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00888867038929), received between Aug 6, 2018 and Apr 30, 2026 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT DURING THE SHOULDER STABILIZATION AS PART OF A LABRAL REPAIR, THE CURVED TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THIS EXTENDED THE SURGERY BY ONE HOUR. 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: Insufficient Information

  MAUDE report 25046524 ↗
• MalfunctionMar 12, 2026Physical Resistance/Sticking

  ON 19-FEB-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6068-45L LASSO WOULD NOT SLIDE THE WIRE WELL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578810 ↗
• MalfunctionSep 16, 2025Break; Break

  ON 08/26/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-6068-45L 45 DEG CURVE LEFT QUICKPASS LASSO HAD A PORTION OF THE DEVICE BREAK OFF. THIS WAS DISCOVERED DURING A LABRAL REPAIR WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064062 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE TIP OF THE QUICKPASS LASSO SNAPPED OFF DURING USE. THE SURGEON PULLED THE DEVICE OUT VERY EASILY AND HE WAS NOT TOO CONCERENED AS NOTED HE WAS HEAVY HANDED WITH THE DEVICE. ALL FRAGMENTS 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 DIFFERENT DEVICE. THE SURGEON USED ANOTHER QUICKPASS LASSO WHICH HE ALREADY HAD OPENED (25 DEGREES). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071034 ↗
• MalfunctionApr 21, 2025Break; Break

  ON 04/03/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6068-45L QUICKPASS LASSO TIP BROKE OFF DURING SURGERY ON THE LABRUM. PER FACILITY" IT IS UNCLEAR WHETHER ANY BROKEN PIECES REMAIN INSIDE THE BODY, AND WE REQUESTED THE SALES REPRESENTATIVE FOR MORE INFORMATION."

  Patient problems: Insufficient Information

  MAUDE report 21872484 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY FOR A SHOULDER INSTABILITY THE SHAFT BROKE OFF AT THE TIP WHEN THE DEVICES WAS LEANED ON THE HUMERUS. THE BROKEN PIECE WAS RETRIEVED OUT OF 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 20864500 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILISATION SURGERY THE DEVICE SNAPPED. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 20212691 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL RAMP REPAIR SURGERY CORKSCREW TIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THE SURGICAL TECHNIQUE WAS CHANGED TO AN ALL-INSIDE MENISCAL REPAIR. 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 DO A SECOND SURGERY. UPDATE SWIT 12-AUG-2024: FURTHER INFORMATION WAS PROVIDED THAT THE LASSO HAD A CORKSCREW/TWISTED SHAPED TIP WHICH BROKE OFF. IT WAS FURTHER CONFIRMED THAT THE SURGEON CHANGED TO DO AN ALL-INSIDE MENISCAL REPAIR AS IT WAS NO LONGER POSSIBLE TO DO IT WITH A LASSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988355 ↗
• MalfunctionJul 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR SURGERY TIP BROKE OFF. THE PARTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE (S&N LASSO). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669933 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE TIP OF THE DEVICES WITH THE PART NUMBER AR-6068-45L BROKE OFF. 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 19619752 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE TIP OF THE DEVICES WITH THE PART NUMBER AR-6068-45L BROKE OFF. 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 19619682 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE THREADS/LASSOS TORE APART. 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 19482692 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY TWO THREADS/LASSOS TORE APART. 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 19477075 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE SURGERY. NO PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 08-JUL-2021: IT WAS CONFIRMED THAT NOTHING BROKE INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390647 ↗
• MalfunctionMay 9, 2024Material Frayed; Material Frayed

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-6068-45L QUICKPASS LASSOS WIRE FRAYED. IT ESSENTIALLY SPLIT INTO TWO. THIS OCCURRED DURING A LABRAL REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 19277561 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A GLENOID LABRAL LESION REPAIR SURGERY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER (SMITH&NEPHEW ACCUPASS). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846308 ↗
• MalfunctionDec 7, 2022Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC STABILIZATION SURGERY, THE LASSO TIP BROKE-OFF INSIDE THE PATIENT. THIS TOOK SOME TIME TO RETRIEVE BUT WAS SUCCESSFULLY RETRIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER, AR-6068-45L, LOT NUMBER: 2228124429. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931217 ↗
• MalfunctionAug 29, 2022Break; Use of Device Problem

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC STABILIZATION SURGERY THE SURGEON WAS USING A 45 CURVE LEFT QUICKPASS LASSO IN A STABILIZATION CASE. HE REPORTS THAT HE PUT A LOT OF FORCE THROUGH THE ITEM WHICH THEN SNAPPED OFF AT THE TIP. THE BROKEN PIECE WAS EASILY RETRIEVED AND THERE WAS NO INJURY TO THE PATIENT. THE TEAM OPENED ANOTHER OF THE SAME ITEM AND COMPLETED THE CASE WITHOUT ANY FURTHER ISSUES. THE TEAM DISPOSED OF THE BROKEN ITEM. THE CONSULTANT AND THE TEAM WERE NOT CONCERNED, HE SAID HE WAS DEFINITELY PUTTING TOO MUCH FORCE THROUGH THE ITEM. 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 15310897 ↗
• InjuryAug 24, 2020Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION THE TIP OF THE INSTRUMENT CAUGHT AGAINST THE GLENOID, AND BROKE OFF. THE PART REMAINED INSIDE THE PATIENT AND THE SURGERY WAS CHANGED TO AN OPEN STABILIZATION. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. UPDATE 13-AUG-2020: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN PART WAS RETRIEVED, HOWEVER THE SURGEON SPENT OVER AN HOUR TRYING TO GET IT ARTHROSCOPICLY, AS IT FELL DOWN TO THE INFERIOR CAPSULAR. THE SURGEON THEREFORE CHANGED THE PROCEDURE TO AN OPEN ONE TO RETRIEVE THE DEVICE OUT OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10443208 ↗
• InjuryAug 6, 2018Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILISATION SURGERY THE TIP OF THE DEVICE BROKE INSIDE THE PATIENT. ALL THE BROKEN FRAGMENTS ARE RETRIEVED AND NOTHING WILL REMAIN INSIDE THE PATIENT. THE SURGEON CHANGED THE SURGICAL TECHNIQUE FROM ARTHROSCOPIC TO OPEN. THIS WAS NECESSARY TO RETRIEVE THE BROKEN FRAGMENT.

  Patient problems: No Code Available

  MAUDE report 7751161 ↗