Arthrex® AR-4068-90LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867031531), received between Dec 21, 2021 and Oct 10, 2024 — classified as 9 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A BANKART LESION / LABRUM SURGERY THE WIRE BROKE AS SOON AS THE TIP WAS INSERTED INTO THE TISSUE. 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. ***UPDATE DW 07-OCT-2024. FURTHER INFORMATION WAS PROVIDED THAT THE TIP OF THE DEVICE BECAME BENT AS SOON AS THE SURGEON TRIED TO PULL THROUGH THE DEVICE BELOW THE TISSUE BRIDGE WHICH RESULTED IN THE BROKEN WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417606 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A BANKART LESION / LABRUM SURGERY THE WIRE BROKE AS SOON AS THE TIP WAS INSERTED INTO THE TISSUE. 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. UPDATE DW 07-OCT-2024: FURTHER INFORMATION WAS PROVIDED THAT THE TIP OF THE DEVICE BECAME BENT AS SOON AS THE SURGEON TRIED TO PULL THROUGH THE DEVICE BELOW THE TISSUE BRIDGE WHICH RESULTED IN THE BROKEN WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417594 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A BANKART LESION / LABRUM SURGERY THE WIRE BROKE AS SOON AS THE TIP WAS INSERTED INTO THE TISSUE. 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. UPDATE 07-OCT-2024. FURTHER INFORMATION WAS PROVIDED THAT THE TIP OF THE DEVICE BECAME BENT AS SOON AS THE SURGEON TRIED TO PULL THROUGH THE DEVICE BELOW THE TISSUE BRIDGE WHICH RESULTED IN THE BROKEN WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417571 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A BANKART LESION / LABRUM SURGERY THE WIRE BROKE AS SOON AS THE TIP WAS INSERTED INTO THE TISSUE. 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. UPDATE DW 07-OCT-2024: FURTHER INFORMATION WAS PROVIDED THAT THE TIP OF THE DEVICE BECAME BENT AS SOON AS THE SURGEON TRIED TO PULL THROUGH THE DEVICE BELOW THE TISSUE BRIDGE WHICH RESULTED IN THE BROKEN WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417569 ↗
• MalfunctionJun 10, 2024Failure to Advance; Failure to Advance

  ON 11/18/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-4068-90L SUTURELASSOS WIRE WAS UNABLE TO PASS THROUGH. THIS OCCURRED DURING A LABRAL REPAIR ON 11/16/20222 WHEN THE WIRE WAS UNABLE TO PASS THROUGH. A PREVIOUS WIRE FROM AN AR-4068-90R WAS THEN TESTED IN BUT WAS UNABLE TO SHUTTLE THROUGH COMPLETELY. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499171 ↗
• MalfunctionApr 30, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE WIRES ON THE AR-4068-90L WOULD NOT ADVANCE. THERE WAS NO PATIENT INVOLVEMENT AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211477 ↗
• MalfunctionSep 19, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-4068-90L SUTURELASSO SD, 90° CURVE LEFT, HAD AN ISSUE. WHILE THE SURGEON WAS COMPLETING A LABRAL REPAIR PROCEDURE ON (B)(6) 2023, HE WAS USING THE LASSO TO PASS THE REPAIR SUTURE THROUGH THE LABRUM. WHEN HE WAS GOING THROUGH THE LABRUM, THE TIP OF THE LASSO BROKE. THE BROKEN PIECE WAS REMOVED, AND THERE WAS NO HARM TO THE PATIENT. A SECOND LASSO WAS USED TO COMPLETE THE CASE. THE DEVICE WAS DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA EMAIL: THERE WAS NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773050 ↗
• MalfunctionMar 14, 2022Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE NITINOL WIRE WAS TORN. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT 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 13757304 ↗
• MalfunctionDec 21, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LABRUM REFIXATION THE NITINOL WIRE OF THE DEVICE BROKE. NO PART OF THE DEVICE BROKE OFF. 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 13054389 ↗