Arthrex® AR-4068HLRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867300217), received between Dec 15, 2023 and Mar 30, 2026 — classified as 12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT DURING A HIP LABRUM SURGERY THE TIP OF THE DEVICE BROKE. NO PART OF THE DEVICE REMAINED INSIDE 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 24716838 ↗
• MalfunctionFeb 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC HIP SURGERY THE FRONT PART OF THE DEVICE GOT BENT AND COULD NO LONGER BE USED WITHOUT BREAKING OFF. 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 24413635 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY ONE DEVICE BROKE AND A SECOND DEVICE BENT AT THE TIP. THE BROKEN PART WAS REMOVED 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 24258530 ↗
• MalfunctionFeb 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY ONE DEVICE BROKE AND A SECOND DEVICE BENT AT THE TIP. THE BROKEN PART WAS REMOVED 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 24258485 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY, THE TIP OF THE DEVICE BROKE WHEN IT WAS ATTACHED TO THE HIP BEFORE PRESSURE WAS APPLIED. NO PARTS REMAINED IN 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 24160185 ↗
• MalfunctionJan 5, 2026Break

  ON 15-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE AR-4068HL SWIFTSTITCH HIP SUTURE PASSER TIP OF THE SWIFTSTITCH BROKE WHILE TRYING TO PASS THE REPAIR SUTURE THROUGH THE LABRUM FOR AN ARTHROSCOPIC HIP LABRAL REPAIR. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957151 ↗
• MalfunctionMay 5, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 04/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK®SOFT ANCHORS BACKED OUT, AN AR-3638DHS-2 DISPOSABLES KITS HANDLE BENT, AND AN AR-4068HL SWIFTSTITCH¿ SUTURE PASSER BENT. THIS OCCURRED DURING A HIP ARTHROSCOPY ON (B)(6) 2025 WHERE ADDITIONAL AR-3636H WAS USED, AND A BIRDBEAK WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 21959301 ↗
• MalfunctionMar 20, 2025Break; Break

  ON (B)(6)2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4068HL SWIFTSTITCH SUTURE PASSER WAS INTRODUCED TO THE HIP JOINT FOR AN ACETABULAR LABRAL REPAIR PROCEDURE USING 1.8 KNOTLESS FIBERTAK ANCHOR ON (B)(6)2025. THE REPAIR SUTURE WAS GRASPED BY THE SWIFTSTITCH, AND UPON PASSING THROUGH THE LABRUM, THE BASE OF THE SWIFTSTITCH NEEDLE BROKE. THE SWIFTSTITCH DID NOT PENETRATE THE ACETABULUM TO CAUSE THIS, AND THE SURGEON BELIEVED THIS WAS DUE TO A FAULTY DEVICE. THIS OCCURRED DURING USE, WITH NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/11/2025: ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY OR KNOWN ANESTHESIA ADMINISTERED TO THE PATIENT. A NEW AR-4068HL WAS OPENED TO COMPLETE THE CASE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653892 ↗
• MalfunctionOct 9, 2024Use of Device Problem; Device Damaged by Another Device; Use of Device Problem; Device Damaged by Another Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4068HL SWIFTSTITCH SUTURE PASSER FRAYED THE SUTURE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 9/19/2024: THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY LABRAL REPAIR PROCEDURE ON 9/12/2024. THE SWIFTSTITCH SUTURE PASSER FRAYED AN AR-7216 FIBERWIRE, WHICH BROKE. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT. THE CASE WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER. IT WAS DELAYED ABOUT TWO MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408358 ↗
• MalfunctionSep 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2024, A SALES REPRESENTATIVE VIA SEMS-06642019 REPORTED THAT AN AR-4068HL SWIFTSTITCH HIP SUTURE PASSER HAD CUT THROUGH THE SUTURE NUMEROUS TIMES. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185178 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE TIP BROKE OFF DURING THE FIRST STITCH. THE BROKEN TIP WAS RETRIEVED FROM THE PATIENT. 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 19595455 ↗
• MalfunctionDec 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK PULLED OUT OF THE BONE. THE KNOTLESS HIP FIBERTAK WAS INITIALLY INSERTED USING THE 20-DEGREE CURVED DRILL GUIDE AND THE NEW 1.8 FLEXIBLE FLUTED DRILL AR-3600ND-2HF. THE ANCHOR WAS INSERTED, AND THE REPAIR SUTURE WAS PASSED THROUGH THE LABRUM. THE REPAIR STITCH WAS CONVERTED INTO THE ANCHOR AND TENSIONED DOWN TO PULL THE LABRUM UP. WHEN TENSIONING THE REPAIR SUTURE, THE ANCHOR PULLED OUT OF THE BONE. ADDITIONALLY, WHEN USING AN AR-4068HL SWIFTSTITCH SUTURE PASSER SHREDDED THE REPAIR SUTURES UPON PASSING THROUGH. THE SWIFTSTITCH SUTURE PASSER WAS SWITCHED FOR ANOTHER ONE, AND THE PROCEDURE WAS CONTINUED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 11/22/2023: THE CASE WAS COMPLETED USING ANOTHER AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK. THE PATIENT HAD NORMAL BONE QUALITY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340577 ↗