ACCU-PASS 23-2005Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556724569), received between Oct 15, 2020 and May 5, 2026 — classified as 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, THE CURVED TIP OF THE ACCUPASS SNAPPED OFF WHILE THE SURGEON WAS PASSING THE CRESCENT TIP THROUGH THE TISSUE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082187 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE SURGEON WAS USING THE ACCU-PASS DIRECT CRESCENT XL TO PASS THE SUTURE THROUGH THE LABRUM, THE DEVICE BROKE. NO PART OF THE DEVICE BROKE OFF THE MAIN BODY OF THE DEVICE, IT WAS REMOVED BY PULLING THE DEVICE OUT OF THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898845 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE SURGEON WAS USING THE ACCU-PASS DIRECT CRESCENT XL TO PASS THE SUTURE THROUGH THE LABRUM, THE DEVICE BROKE. NO PART OF THE DEVICE BROKE OFF THE MAIN BODY OF THE DEVICE, IT WAS REMOVED BY PULLING THE DEVICE OUT OF THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896570 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER PASSING THROUGH THE CANNULA THE ACCU-PASS TIP, IT WAS IDENTIFIED THAT THE ANGLE CHANGED, THE TIP DID NOT COME LOOSE INSIDE THE PATIENT. IT WAS REMOVED FROM INSIDE THE JOINT AND WHEN LOOKED OUTSIDE IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646512 ↗
• InjuryMar 24, 2023Break; Break

  IT WAS REPORTED THAT DURING A SLAB-REPAIR, WHEN THE PHYSICIAN PASSED THE SUTURE, THE ACCU-PASS BENT AND BROKE. THE BROKEN PART WAS SUCCESSFULLY RETRIEVED BY THE PHYSICIAN USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612476 ↗
• InjuryMar 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE SPECIALIST REQUESTED AN ACCU-PASS WITH A MINITAPE POINT, THE DEVICE WAS LOCATED INSIDE THE JOINT, BUT DECIDED TO RELOCATE IT, AND WHEN TRYING TO PASS THE POINT AGAIN, THE ACCU-PASS BENT. THE SPECIALIST TRIED TO RETRIEVE THE NEEDLE, BUT IT DID NOT GO BACK, AND THE DEVICE BROKE AT THE JUNCTION. THE BROKEN PIECES WERE TAKEN OUT WITH CAUTION TOGETHER WITH THE CANNULA. THE PROCEDURE WAS COMPLETED WITH A 10-MIN DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT'S HEALTH WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478987 ↗
• InjuryJan 2, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ACCU-PASS DEVICE BROKE DUE TO TISSUE RESISTANCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082904 ↗
• InjuryDec 27, 2022Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE ACCU-PASS DIRECT TIP BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITH AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING AN ARTHREX COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056703 ↗
• InjuryAug 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ROTATOR CUFF SURGERY IN SHOULDER, THE SMALL DISTAL TIP OF THE HOOK OF THE ACCUPASS DIRECT XL BROKE OFF WHILE RETRACTING THE SUTURE INTO THE DEVICE. THE TIP WAS LOCATED IN THE JOINT ARTHROSCOPICALLY AND CONFIRMED WITH FLUOROSCOPY. A SUCTION MAGNET WAS USED TO REMOVE THE TIP. SUTURE WAS LEFT SECURED TO THE PATIENT VIA SUTURE ANCHOR. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A BACK-UP DEVICE INSTEAD. THE PATIENT IS FINE AND DOING WELL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218821 ↗
• InjuryApr 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE DOCTOR DID NOT FOLLOW THE CORRECT ACCU-PASS SUTURE PASSER TECHNIQUE. THE DOCTOR DID NOT KNOW HOW TO USE THE PASSER TO GET TO THE ANCHOR WIRE AND WHILE FORCING THE PIECE, IT FRACTURED THE TIP OF THE ACCU-PASS. THE PIECE OF THE PRODUCT WAS LEFT INSIDE OF THE PATIENT. NO DELAY WAS REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14138889 ↗
• InjuryJan 25, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE SURGEON PASSED THE ACCUPASS DIRECT CRESCENT XL THROUGH THE LABRUM AND WHEN HE REMOVED THE DEVICE FROM THE LABRUM HAVING PASSED THE SUTURE, IT WAS OBSERVED THAT THE TIP OF THE HOOK WAS MISSING; TIP WAS REMOVED FROM PATIENT BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE AND A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342400 ↗
• InjuryDec 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER SCOPE (RC) CASE, THE ACCU-PASS DIRECT CRESCENT XL WAS BEING USED ON A LOOSE PDS 1. THE HOOKED TIP PART OF THE PASSER BROKE HALFWAY WHILE PULLING OUT OF PATIENT¿S SHOULDER. AN II WAS CALLED TO FIND THE MISSING ¿HOOKED TIP¿ WHICH WAS FOUND AND REMOVED FROM PATIENT. PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043727 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHEN THE ACCU-PASS SUTURE PASSER PASSED THROUGH THE SHOULDER LABRUM, THE SHAFT WAS BADLY BENT. THE PASSER WAS REMOVED OUT OF THE JOINT AND AS TRYING TO BEND IT BACK IT BROKE. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046613 ↗
• InjuryJun 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL TRANSPLANT, THE ACCU-PASS SUCCESSFULLY PASSED FIRST 3 SUTURES. ON FINAL ATTEMPT THE NEEDLE WAS SUCCESSFULLY PUSHED THROUGH THE KNEE CAPSULE BUT THE HOOK WAS NO LONGER ATTACHED TO THE DEVICE. THE HOOK WAS SUCCESSFULLY LOCATED IN THE FLUID BAG. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. NO FURTHER COMPLICATIONS TO PATIENT WERE REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965190 ↗
• MalfunctionMay 7, 2021Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT, DURING PROCEDURE, THE TIP OF THE ACCU-PASS DIRECT CRESCENT HAD A DEFECT, THEREFORE, IT DID NOT HOOK ON/GRASP THE SUTURE CORRECTLY. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY NOR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793938 ↗
• MalfunctionMar 28, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, OUTSIDE THE PATIENT, THE ACCU-PASS DIRECT CRESCENT XL TIP IS CHIPPED BUT STILL ON. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINS. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580376 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT THE ACCU-PASS DID NOT HAD A HOOK ON THE END; IT SEEMS TO BE BROKEN. THE DEVICE WAS NOT USED. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE. NO COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10933009 ↗
• InjuryNov 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE SURGEON DID NOT FELL A HARD HIT TO THE FEMORAL NECK AND THE DIRECT NECK OF THE ACCUPASS BROKE WHEN TRYING TO PIERCE THE CAPSULE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10807112 ↗
• InjuryOct 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, WHEN THE SURGEON WAS PUSHING THE ACCU-PASS DIRECT SUTURE PASSER CRESCENT XL THROUGH THE CAPSULE THE TIP OF THE ACCUPASS BROKE DUE TO A HIT TO THE FEMORAL NECK. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10687038 ↗