Arthrex® AR-6069-45RRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867115873), received between Nov 27, 2023 and Oct 22, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A BANKART SURGERY THE SHUTTLING SUTURE WAS NOT ROLLING OUT OF THE HOOK. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504380 ↗
• MalfunctionJun 7, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A QUANTITY TWO AR-6069-45R DID NOT PROJECT THE MONOFILAMENT AND WERE COMPLETELY JAMMED. THE MONOFILAMENT SEEMED WAS STUCK INSIDE THE DEVICE AND THE WHEEL STOPPED TURNING. A THIRD AR-6069-45R FROM A DIFFERENT LOT NUMBER WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THE REP REPORTED NO PIECE BROKE OFF FROM THE INSTRUMENTS.

  Patient problems: Insufficient Information

  MAUDE report 19487893 ↗
• MalfunctionJun 5, 2024Failure to Advance; Failure to Advance

  THE SURGEON OPENED REELPASS LASSO, PRIMED THE INSTRUMENT BY PULLING THE FIRST METER OF WIRE, AFTER MAKING FIRST PASS THROUGH THE LABRUM, THE REEL WOULD NOT DEPLOY ANY MORE, SUTURE PAST AROUND 5CM. THEN IT WAS RETRIEVED OUT THE SHOULDER AND IT WAS IMPOSSIBLE TO ROLL ANY MORE THROUGH. THE PRODUCT WAS DISCARDED AND ANOTHER ONE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470794 ↗
• MalfunctionJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 5/27/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6069-45L AND AN AR-6069-45R SUTURE LASSO HAD AN ISSUE DURING A RIGHT SHOULDER REPAIR PROCEDURE. AS THEY BEGAN TO REPAIR THE LABRUM, ANTERIOR THEN POSTERIOR, THEY OPENED UP TWO REELPASS SUTURE PASSERS, ONE LEFT AND ONE RIGHT. THEY USED THE RIGHT ONE FIRST, WHICH SEEMED TO WORK OUT OF THE PACKAGE, BUT ONCE IT WAS INSIDE THE JOINT IT WOULD ONLY FEED A COUPLE ON INCHES OF MONOFILAMENT INTO THE JOINT. THE PASSER WAS REMOVED FROM THE SHOULDER AND MONOFILAMENT PULLED OUT OF THE PASSER IN ORDER TO CLEAR ANY BLOCKAGES. IT WAS THEN REINTRODUCED INTO THE SHOULDER BUT THE ISSUE PERSISTED. A SECOND 45R REELPASS WAS OPENED BUT THE SAME ISSUE HAPPENED WITH THIS ONE AS WELL. TO SUCCESSFULLY COMPLETE THE ANTERIOR REPAIR A NON-ARTHREX PRODUCT WAS OPENED. TURNING TO THE POSTERIOR SIDE WE BEGAN USING THE 45L REELPASS, BUT THIS TOO EXPERIENCED THE SAME ISSUE AS THE 45RS. ONCE IT WAS DETERMINED THAT THE PASSER WOULD NOT EXPEL MONOFILAMENT, A NON-ARTHREX PRODUCT WAS OPENED IN ORDER TO COMPLETE THE REPAIR. THE PROCEDURE WAS COMPLETED WITH NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469456 ↗
• MalfunctionJun 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON 09/06/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-6069-45R AND AR-6069-45L SUTURE LASSO IMPLANT BECAME STUCK AND WOULD NOT DEPLOY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460404 ↗
• MalfunctionJun 4, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON 02/14/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6069-45L AND AR-6069-45R SUTURE LASSO WOULD NOT UNSPOOL THE PASSING SUTURE. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458400 ↗
• MalfunctionJun 3, 2024Failure to Fire; Failure to Fire

  ON 10/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (3) AR-6069-45R REELPASS SUTURELASSO NO PDS SUTURE IS EXPELLED FROM THE TIP. THIS OCCURRED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449829 ↗
• MalfunctionJun 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON 11/22/2022 BY A DISTRIBUTOR VIA SEMS THAT AN AR-6069-45R REELPASS SUTURE GOT STUCK AND THE LASSO WOULD NOT DEPLOY. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448229 ↗
• MalfunctionMay 24, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED DURING A SLAP REPAIR OF A LEFT SHOULDER. OUT OF THE PACKAGE THE SUTURE EXPELLED A LITTLE BIT BUT STOPPED. THE NURSE THEN PULLED A DECENT AMOUNT OF THE SUTURE OUT TO TRY TO CLEAR ANY OBSTRUCTIONS. THE SUTURE WAS THEN CUT AND THE WHEEL ROLLED TO EXPEL SUTURE WHICH SEEMED TO WORK PROPERLY. ONCE IN THE JOINT, THE SUTURE WOULD ONLY EXPEL A SMALL AMOUNT. THE CASE WAS SUCCESSFULLY COMPLETED BY OPENING UP ANOTHER REELPASS LASSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390477 ↗
• MalfunctionMay 16, 2024Defective Device; Defective Device

  ON 02/17/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-6069-45R SUTURE LASSO IS NOT WORKING. THIS WAS DISCOVERED DURING AN UNKNOWN TIME WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329577 ↗
• MalfunctionApr 30, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A POSTERIOR LABRAL REPAIR. UPON OPENING THE PACKAGE OF THE AR-6069-45R, THE MONOFILAMENT WOULD NOT FEED WHEN THE WHEELS WERE ROLLED. THE MONOFILAMENT WAS THEN PULLED WITH A HEMOSTAT TO TRY TO JUMP START THE MECHANISM. THIS WORKED BRIEFLY BUT WHILE ATTEMPTING TO FEED THE MONOFILAMENT INTO THE JOINT FOR THE FIRST ANCHOR THE DEVICE STOPPED EXPELLING MONOFILAMENT BEFORE THE DEVICE COULD BE REMOVED FROM THE JOINT. THE MONOFILAMENT WAS AGAIN PULLED WITH A HEMOSTAT TO EXPEL THE SUTURE AND GET ANY KINKS OUT, AND AGAIN THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER MANUFACTURER'S SUTURE PASSER. SEE SOURCE DATA ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 19212281 ↗
• MalfunctionMar 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN (B)(6) SUTURE LASSO MONOFILAMENT WAS JAMMED AND WOULD NOT DEPLOY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE PATIENT WAS UNHARMED, A NEW LASSO WAS OPENED, AND THE CASE CONTINUED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921632 ↗
• MalfunctionFeb 27, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 2/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING A LABRAL REPAIR CASE ON (B)(6) 2024, THE WHEEL ON THE REELPASS SUTURE LASSO, AR-6069-45R, WAS DEPLOYING SOME FILAMENT, BUT WOULD GET STUCK OFTEN AND NOT DEPLOY. A NEW ONE WAS OPENED AND WORKED WITHOUT ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793930 ↗
• MalfunctionFeb 22, 2024Defective Device; Defective Device

  ON 02/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6069-45R LASSO PIN WOULDN'T COME OUT AND RETRACT. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 2/9/24: THE DATE OF THE PROCEDURE WAS (B)(6) 2024. THE PROCEDURE PERFORMED WAS A SHOULDER LABRUM REPAIR. THE CASE WAS COMPLETED WITH A NEW SUTURE LASSO. NO IMAGES OR VIDEOS WERE TAKEN. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18761537 ↗
• MalfunctionFeb 15, 2024Failure to Advance; Failure to Advance

  ON 1/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6069-45R REELPASS SUTURE LASSO MALFUNCTIONED. WHEN THE SURGEON ADVANCED THE WHEELS TO DEPLOY THE MICROFILAMENT, ONLY SOME WOULD COME OUT AND THEN IT WOULD STOP. THIS WAS DISCOVERED DURING A ROTATOR CUFF CASE. THE CASE WAS COMPLETED WITH ANOTHER AR-6069-45R WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18713348 ↗
• MalfunctionJan 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RAMP LESION THE SHUTTLE SUTURE OF THE DEVICE BECAME STUCK WHILE THE DEVICE WAS USED IN THE JOINT AND THE DEVICE COULD NOT BE USED ANYMORE. 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 18444716 ↗
• MalfunctionJan 3, 2024Failure to Advance; Failure to Advance

  ON 12/4/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT QTY. 2 OF AN AR-6069-45R REELPASS SUTURE LASSO HAD AN ISSUE DURING A LABRUM PROCEDURE ON (B)(6) 2023. THE SURGEON COULDN¿T USE THE LASSO AS THE WHEEL OF THE LASSO WASN¿T WORKING, AND THE LASSO CABLE DIDN¿T GO OUT. THE MECHANISM INSIDE DIDN'T SEEM TO WORK; THE SURGEON WASN¿T ABLE TO ADVANCE THE TAIL OF THE WIRE. THE DEVICES WILL NOT BE RETURNED FOR AN EVALUATION. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED. ON 12/28/2023, THE DISTRIBUTOR PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: NO PIECES OF THE INSTRUMENTS BROKE INSIDE THE PATIENT. ANOTHER AR-6069-45R REELPASS SUTURE LASSO WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A 14 MINUTE CASE DELAY REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435729 ↗
• MalfunctionJan 2, 2024Failure to Advance; Failure to Advance

  ON 12/4/2023, IT WAS REPORTED BY A DISTRIBUTOR THAT (B)(4) OF AN AR-6069-45R REELPASS SUTURE LASSO HAD AN ISSUE DURING A LABRUM PROCEDURE ON (B)(6) 2023. THE SURGEON COULDN¿T USE THE LASSO AS THE WHEEL OF THE LASSO WASN¿T WORKING, AND THE LASSO CABLE DIDN¿T GO OUT. THE MECHANISM INSIDE DIDN'T SEEM TO WORK; THE SURGEON WASN¿T ABLE TO ADVANCE THE TAIL OF THE WIRE. THE DEVICES WILL NOT BE RETURNED FOR AN EVALUATION. THIS OCCURRED DURING USE WITH NO PATIENT HARM. NO PIECES OF THE INSTRUMENTS BROKE INSIDE THE PATIENT. ANOTHER AR-6069-45R REELPASS SUTURE LASSO WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A 14 MINUTE CASE DELAY REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18431620 ↗
• MalfunctionNov 27, 2023Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SUTURE ENTANGLED AND THE SUTURE WAS STUCK IN THE DRIVER. A SECOND DEVICE FROM THE SAME BATCH WAS OPENED TO CARRY ON THE SURGERY BUT IT WAS ALREADY DEFECTED, THE SUTURES WAS OUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER (CONMED). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208935 ↗