Arthrex® AR-6069-45LRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867115866), received between Aug 10, 2021 and Jun 13, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  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 19530163 ↗
• MalfunctionJun 12, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE WIRE WOULD NOT ADVANCE WHEN THE WHEEL AS TURNED. ANOTHER AR-6069-45L WAS USED TO COMPLETE THE CASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521611 ↗
• MalfunctionJun 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6069-45L SUTURE LASSO SHUTTLE SUTURE WAS NOT DEPLOYING AS THE WHEEL WAS STUCK. THIS OCCURRED DURING A LABRAL REPAIR ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A NEW AR-6069-45L WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491759 ↗
• MalfunctionJun 6, 2024Defective Device; Defective Device

  ON (B)(6) 2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-6069-45L SUTURE LASSO DID NOT WORK AT ALL. THIS WAS DISCOVERED DURING USE IN A SHOULDER PROCEDURE ON (B)(6) 2022 WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478666 ↗
• 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 19469351 ↗
• MalfunctionJun 4, 2024Mechanical Jam; Mechanical Jam

  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 19460281 ↗
• MalfunctionMay 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE REELPASS SUTURE JAMMED DURING PROCEDURE. ALSO PDS SUTURE SNAPPED MULTIPLE TIMES. BEFORE THE PROCEDURE . THE DEVICE WAS 'PRIMED' BY PULLING OUT 1 METRE OF SUTURE AND ENSURING IT WAS WORKING SMOOTHLY. THE SURGEON TOOK APART THE REELPASS AND UNTANGLED THE SPOOL OF PDS SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374362 ↗
• MalfunctionMay 22, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING A RAMP LÉSION SURGERY IT WAS NOT POSSIBLE TO DELIVER THE SUTURE OUT OF THE HANDLE. 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 19373423 ↗
• MalfunctionMay 16, 2024Failure to Advance; Failure to Advance

  ON 10/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-6069-45L REELPASS SUTURELASSO WAS STUCK. THIS OCCURRED DURING AN UNKNOWN PROCEDURE WHEN THE DEVICE WHEEL WOULD NOT ADVANCE THE MONOFILAMENT WIRE INSIDE. THERE WAS NO PATIENT EFFECT REPORTED, AND NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331931 ↗
• MalfunctionMay 16, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED ON 10/10/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6069-45L SUTURE LASSO WHEEL WOULD NOT ADVANCE MONOFILAMENT WIRE INSIDE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330568 ↗
• MalfunctionApr 19, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED DURING A PROCEDURE, THE REEL PASS LASSO, AR-6069-45, DID NOT SHUTTLE SUTURE PROPERLY USING CRANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142889 ↗
• MalfunctionApr 18, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED DURING A BANKART REPAIR OF THE LEFT SHOULDER A QUANTITY TWO AR-6069-45L (LOT: 12221645) MALFUNCTIONED. WHEN THE PRODUCT WAS OPENED, THE SCRUB TECH ATTEMPTED TO RUN THE SUTURE BY ROLLING THE WHEEL TO MAKE SURE IT WORKED BEFORE HANDING IT TO THE SURGEON. THE MONOFILAMENT FROM THE DEVICE CAME OUT ABOUT TWO INCHES AND THEN STOPPED DESPITE CONTINUING TO ROLL THE WHEELS TOGETHER AND INDEPENDENTLY. THE SCRUB TECH THEN TOOK A HEMOSTAT AND TRIED TO PULL THE SUTURE OUT THE TIP AS WELL AS ROLL THE WHEEL TO GET THE SUTURE TO RUN BUT IT STILL DID NOT FEED. A SECOND DEVICE WAS OPENED TO REPLACE THE FIRST ONE BUT THE EXACT SAME THING HAPPENED AS THE FIRST. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER MANUFACTURER'S DEVICE. SEE SOURCE DATA ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19136021 ↗
• MalfunctionAug 10, 2021Defective Device

  IT WAS REPORTED DURING A LEFT SHOULDER ARTHROSCOPY WITH CAPSULORRAPHY, ONCE THE SURGEON INTRODUCED THE REELPASS INTO THE JOINT OF THE PATIENT, THE DEVICE FED SOME MONOFILAMENT BUT THEN STOPPED SHORTLY AFTER, NOT LEAVING ENOUGH MONOFILAMENT TO REMOVE THE DEVICE FROM THE JOINT AND RETRIEVE THE MONOFILAMENT. THE SCRUB TECH TRIED TO PRIME THE DEVICE BY FORCEFULLY PULLING SUTURE THROUGH, BUT WHEN REINTRODUCED INTO THE JOINT THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED BY USING A NEW AR-6069-45L WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 12300819 ↗