ACCU-PASS 7210424Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03596010534453), received between Feb 23, 2018 and Apr 17, 2023 — classified as 11 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING SET UP FOR AN ARTHROSCOPIC SHOULDER INSTABILITY PROCEDURE, WHEN OPENING AN ACCU-PASS DEVICE A STING WAS FELT, LOOKING AT THE SLEEVE IT WAS PIERCED BY THE DEVICE NOZZLE. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753462 ↗
• MalfunctionApr 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE THE ANCHORS OF TWO (2) ACCU PASS BROKE OFF, AND THE HANDLES DETACHED FROM THE STEMS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A COMPETITORS DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675979 ↗
• InjuryFeb 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE WITH ADHERED BONE FRAGMENT, THE SURGEON TRIED TO GO THROUGH THE FRAGMENT, AFTER SEVERAL ATTEMPTS BENT AND NO LONGER RETRACTED THE THREAD, IT ALSO BROKE (CASE (B)(4)). THE DEVICE BROKE BETWEEN THE HANDLE AND THE SHAFT, EXTERNAL TO THE PATIENT. FINALLY, THE DOCTOR WAS ABLE TO PERFORM THE SUTURE AND FINISH THE SURGERY AFTER REMOVING A BIT OF BONE THAT WAS LOCATED BETWEEN THE LABRUM AND THE GLENOID, WITH THE FORCEPS FROM THE ELITE INSTRUMENT BOX. NO SURGICAL DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16362911 ↗
• InjuryFeb 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE WITH ADHERED BONE FRAGMENT, THE SURGEON TRIED TO GO THROUGH THE FRAGMENT SEVERAL TIMES AND THE ACCUPASS BROKE. THE DOCTOR WAS ABLE TO PERFORM THE SUTURE AND FINISH THE SURGERY WITH THE FORCEPS FROM THE ELITE INSTRUMENT BOX, AFTER REMOVING A BIT OF BONE THAT WAS LOCATED BETWEEN THE LABRUM AND THE GLENOID. NO SURGICAL DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362901 ↗
• InjurySep 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE RIGHT ACCU-PASS SUTURE WAS PASSED TO PASS THE STITCHES AND REPAIR THE INSTABILITY OF THE PATIENT, AT THE TIME OF RESCUING, THE GUIDE BROKE AND THE THREADS COULD NOT BE RESCUED, THE THREADS WERE LEFT LOOSE IN THE PATIENT. ANOTHER GUIDE WAS PASSED BUT IT BROKE IN THE SAME WAY. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A PARROT BEAK CLAMP TO PASS THE STITCHES AND TO MAKE THE REPAIR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15355757 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE ACCU-PASS GUIDE ADVANCES THROUGH THE BEARING LOCATED IN THE HANDLE OF THE DEVICE AND THEN IT IS PASSED TO THE SURGEON, AT THE MOMENT OF PENETRATING THE TISSUE, THE GUIDE ADVANCES IN A SHORT LENGTH AND THEN STOPS ADVANCING, THE SURGEON MAKES A STRONG MOVEMENT INSIDE THE JOINT AND THE ACCU-PASS AT ITS TIP TEARS THE TISSUE, THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644932 ↗
• InjuryOct 18, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER LABRAL REPAIR THE ACCU-PASS SUTURE SHUTTLE BROKE AT THE TIP. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITH GRASPER. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 5-10 MINUTES USING A ARTHREX SUTURE LASSO COMPETITIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652076 ↗
• InjuryJul 1, 2021Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A LABRAL REPAIR, A ACCU-PASS SUTURE SHUTTLE WAS UNABLE TO PROGRESS THE MONOFILAMENT. WHEN REMOVING THE ACCU-PASS FROM PATIENT, THE MONOFILAMENT BROKE LEAVING HALF OF THE MONOFILAMENT IN THE PATIENT AND HALF IN THE DEVICE. THE REMAINING MONOFILAMENT WAS REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104708 ↗
• InjuryMay 11, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, AT THE MOMENT OF PASSING THE SUTURE THROUGH THE ACCU-PASS THROUGH THE LABRUM, AFTER THE ANCHOR WAS PLACED, THE DEVICE BROKE IN THE PART WHERE THE CURVE BEGINS TO THE RIGHT. PART WAS SUCCESSFULLY REMOVED FROM THE PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808974 ↗
• InjuryMay 10, 2021Mechanical Jam; Firing Problem; Mechanical Jam; Firing Problem

  IT WAS REPORTED THAT DURING A LABRAL REPAIR SURGERY, THE ACCUPASS WOULD NOT ADVANCE THE SUTURE TO A CERTAIN POINT AND IT GOT STUCK. A SPARE SUTURE WAS USED BUT THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A SUTURE LASSO FROM ARTHREX COMPANY AS A BACK UP. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803827 ↗
• MalfunctionMar 27, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING SHOULDER INSTABILITY REPAIR ARTHROSCOPY PROCEDURE, THE SUTURE WAS NOT RELEASING PROPERLY FROM THE ACCU-PASS. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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

  MAUDE report 11580055 ↗
• MalfunctionMar 24, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY/ANTERIOR LABRUM REPAIR, OUTSIDE THE PATIENT, USING ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE THE HANDLE COULD NOT BE RELOADED, THE MONOFILAMENT WOULD STOP PROGRESSING ON THE WHEELS. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. 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 11563591 ↗
• MalfunctionMar 22, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A SURGERY THE ACCU-PASS SUTURE SHUTTLE WAS OPENED AND IT HAD A MALFUNCTION, THE PRE-LOADED MONOFILAMENT WAS NOT ABLE TO ROLL IN WITH THE HELP OF A SLIDING WHEEL, IT WAS TIGHT AT ONE END AND AT THE SAME TIME UNABLE TO SLIDE IN THE MONOFILAMENT. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SIGNIFICANT DELAY. NO PATIENT INJURIES OR 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 11537182 ↗
• MalfunctionNov 10, 2020Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY, THE LOOP OF THE ACCU-PASS WAS DAMAGED SINCE IT GOT STUCK IN THE WHEELS THAT ALLOW THE LOOP TO COME OUT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF A DELAY OCCURRED. NO PATIENT INJURY OR 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 Known Impact Or Consequence To Patient

  MAUDE report 10819203 ↗
• MalfunctionAug 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY THE ACCUPASS MONO-FILAMENT WOULD NOT PROGRESS THROUGH THE SHAFT, MAKING IT UNABLE TO BE USED; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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 Known Impact Or Consequence To Patient

  MAUDE report 10365880 ↗
• MalfunctionAug 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY THE ACCUPASS MONO-FILAMENT WOULD NOT PROGRESS THROUGH THE SHAFT, MAKING IT UNABLE TO BE USED; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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 Known Impact Or Consequence To Patient

  MAUDE report 10365864 ↗
• InjuryJul 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN IT WAS ATTEMPTING TO PASS THE SHUTTLE THROUGH THE LABRUM, THE METAL PART OF THE DEVICE BROKE AND SEPARATED FROM THE PLASTIC HANDLE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311798 ↗
• MalfunctionJul 22, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT, DURING A LABRUM REPAIR SURGERY, WHEN THE DR. WAS USING THE "ACCUPASS, 45°, RIGHT" TO PASS THE SUTURE FOR THE REPAIR, THE MONOFILAMENT WOULD NOT WINDED COMPLETELY THROUGH MAKING IT UNABLE TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 Known Impact Or Consequence To Patient

  MAUDE report 10308163 ↗
• MalfunctionJul 22, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT, DURING A LABRUM REPAIR SURGERY, WHEN THE DR. WAS USING THE "ACCUPASS, 45°, RIGHT" TO PASS THE SUTURE FOR THE REPAIR, THE MONOFILAMENT WOULD NOT WINDED COMPLETELY THROUGH MAKING IT UNABLE TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 Known Impact Or Consequence To Patient

  MAUDE report 10307998 ↗
• MalfunctionJul 22, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SURGEON TRIED TO PASS THE MONOFILAMENT THROUGH AND IT WOULDNT PROGRESS, HE THEN REMOVED AND TRIED WITH THE BACK-UP THAT IS SENT IN THE PACK, AGAIN IT WOULDNT PROGRESS. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10307848 ↗
• InjuryJun 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER STABILIZATION, WHEN THE SURGEON WAS TRYING TO PASS THE ACCUPASS THROUGH THE LABRAL TISSUE, THE TIP OF THE ACCUPASS BENT UPWARDS BLUNTING THE END, WHEN IT WAS BEING REMOVED FROM THE JOINT, THE SHAFT BROKE AWAY FROM THE HANDLE. SURGEON THEN ATTEMPTED TO USE A FIRSTPASS MINI, THEN A FIRSTPASS STANDARD AND AT THE END DOCTOR REQUIRED TO USE A CHAMPION PASSER (STRYKER). IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE, NO FURTHER 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 10176340 ↗
• InjuryMay 14, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SHOULDER PROCEDURE THE ACCU-PASS WAS NOT ROLLED IN THE DEVICE. IT WAS FOUND EXTERNAL TO THE PATIENT. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10054724 ↗
• MalfunctionFeb 11, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING SHOULDER INSTABILITY SURGERY, THE DOCTOR MENTIONED THAT IT WAS HARD TO PULL IN AND OUT THE NYLON MONOFILAMENT THROUGH THE SHARP TIP. SOMETIMES IT WORKED PROPERLY AND SOMETIMES IT DID NOT. THEN, HE USED ANOTHER INSTRUMENT (NOT FROM S&N) FOR THE SAME PURPOSE. THE PROCEDURE WAS COMPLETED BY USING A SIXER AND A CLEVER HOOK. THE DEVICE WAS FROM (B)(4). NO DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9696182 ↗
• MalfunctionDec 30, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, PROF. (B)(6) FOUND OUT THAT THE ACCUPASS' MONOFILAMENTS ARE HARD TO PULL OUT AFTER OPENING. IT IS INCREASINGLY MORE DIFFICULT TO PULL OUT THE MONOFILAMENT THROUGH THE WHEELS WITH REPEATED USE. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE FROM CONMED. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9533014 ↗
• MalfunctionOct 14, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE THE DEVICE TIP BROKE. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9189207 ↗