FirstPass 72290129Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00885556694565), received between Jun 17, 2020 and May 5, 2026 — classified as 28 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, (1) FIRSTPASS MINI LEFT BROKE DURING BITING. A FOLLOW-UP MRI WILL BE PERFORMED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN ARTHREX COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25089601 ↗
• MalfunctionMay 1, 2026Failure to Cycle; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING A MENISCUS ROOT REPAIR, WHILE PASSING THE SUTURES, THE NEEDLE OF ONE (1) FIRSTPASS MINI CAME OUT BETWEEN THE CAPTURE DEVICE AND THE EDGE OF THE TOP JAW. AFTER MULTIPLE ATTEMPTS TO PASS THROUGH, THE CAPTURE DEVICE STARTED TO DISLODGE FROM THE TOP JAW, BUT IT DID NOT DETACH COMPLETELY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059080 ↗
• InjuryApr 28, 2026Break

  IT WAS REPORTED THAT DURING A ACL PROCEDURE, THE TIP OF THE FIRST PASS BROKE WHILE ATTEMPTING TO PASS THE WIRE THROUGH THE MENISCUS, DUE TO POOR ANGULATION AND LIMITED WORKING SPACE. A BROKE PIECES WAS REMOVED FROM INSIDE THE PATIENT USING A MENISCUS CLAMP. AN X-RAY WAS SUBSEQUENTLY PERFORMED, WHICH REVEALED THAT AN ADDITIONAL FRAGMENT REMAINED IN THE KNEE. THE PART OF THE FORCEPS REMAINED IN THE LATERAL POSTERIOR BETWEEN THE MENISCUS AND THE CAPSULE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25024041 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS NOTICED THAT THE SELF CAPTURE JAW OF THE FIRSTPASS MINI WAS DISPLACED AND HAD FALLEN OFF AFTER A COUPLE OF PASSES. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310217 ↗
• MalfunctionJan 13, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A QUADRICEPS TENDON REPAIR, DURING THE FIRST ACTUATION OF ONE (1) FIRSTPASS MINI LEFT WITH A #1 VICRYL SUTURE LOADED, THE SUTURE CAPTURE DISLODGED FROM THE TOP JAW, BUT REMAINED ATTACHED TO THE DEVICE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. THE PATIENT'S STATUS IS FINE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055564 ↗
• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE SUTURE PASSER OF THE FIRSTPASS FELL OFF THE DEVICE OUTSIDE THE PATIENT. THE SURGEON TOOK ONE ADDITIONAL FIRSTPASS AND THE LOOKING END FELL OFF INSIDE THE PATIENT WAS EASILY TAKEN OUT BY THE SURGEON. THE PROCEDURE WAS RESUMED, AFTER A DELAY GRATER THAN 30 MIN, USING A SIMILAR S+N DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866352 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE REPLACEMENT SURGERY WITH MENISCUS SUTURE, THE UPPER ARCH OF ONE (1) FIRSTPASS MINI LEFT BROKE WHILE PASSING THE SUTURE OVER THE MENISCUS, LEAVING A SMALL FRAGMENT, ALONG WITH THE RACK, BEHIND. THE BROKEN PIECES WERE REMOVED WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291981 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE UPPER JAW OF TWO FIRSTPASS MINI DISCONNECTED FROM ITS HOUSING. THERE WAS A RISK OF LOSING THE JAW DURING THE ARTHROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WERE NO PIECES LEFT INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986144 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION, ONE (1) FIRSTPASS MINI HAD A PIECE DETACHED FROM THE INSTRUMENT, REMAINING IN THE JOINT. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH A GRASPER FROM THE SMITH AND NEPHEW ELITE SHOULDER SET. THE PROCEDURE WAS COMPLETED AT THAT POINT AND NO FURTHER INSTRUMENTATION REQUIRED. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901135 ↗
• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER STABILIZATION PROCEDURE, THE FIRSTPASS MINI BROKE IN THE SHOULDER, ITS GRIPPER BECAME DETACHED. IT TOOK CONSIDERABLE TIME TO RETRIEVE IT, A SECOND SURGEON CAME TO ASSIST AND IT WAS REMOVED USING A GRASPER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S CURRENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896104 ↗
• MalfunctionJul 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE CAPTURE JAW OF THE SUTURE SNAPPED OFF INSIDE THE PATIENT WHEN PASSING THE SUTURE THROUGH THE TISSUE. THE PIECES WERE REMOVED WITH GRABBERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552295 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLAMP BITE OF THE FIRSTPASS MINI BROKE IN THE JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379182 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TOP JAW OF THE FIRSTPASS MINI, WHERE THE SUTURE IS RETRIEVED, BROKE OFF. A C-ARM WAS USED TO LOCATE THE PIECE, WHICH WAS FOUND IN THE SUCTION BAG AND NOT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359415 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE THE TOP JAW OF THE FIRSPASS MINI FELL OFF. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181691 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIRSTPASS MINI BROKE IN THE PATIENT'S SHOULDER. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, AND THE OPERATING TIME WAS INCREASED. THERE WAS NO IMPACT ON THE PATIENT'S STATE OF HEALTH, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155389 ↗
• MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROOT REPAIR PROCEDURE, THE TOP JAW OF THE FIRSTPASS FELL OFF. IT WAS RETRIEVED OUT OF THE PATIENT SUCCESSFULLY USING A GRASPER AND X-RAY IMAGING WAS PERFORMED. THE PROCEDURE WAS COMPLETED USING AN ACCUPASS 70 DEVICE AND THERE WAS A SURGICAL DELAY OF 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154385 ↗
• MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE FIRSTPASS MINI BECAME DISASSOCIATED FROM THE CAPTURE. THE FIRSTPASS SUTURE CAPTURE (TEETH/JAW) INTERACTED WITH THE SOFT TISSUE, AND THE FORCE OF THE NEEDLE PUSHING THROUGH FORCED THE JAW OUT OF THEIR CAPTURE WINDOW IN THE TOP JAW. THE JAWS WERE PUSHED OUT INTO THE JOINT SPACE AS A SINGLE PIECE AND REMOVE FROM THE PATIENT'S JOINT WITH THE RED HANDLE GRASPER. 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 22066998 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE ROTATOR CUFF REPAIR, THE FIRSTPASS MINI WAS BROKEN. ALL THE PIECES WERE REMOVED FROM INSIDE THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF 2-3 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960402 ↗
• MalfunctionMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SPECIALIST INTRODUCED THE FIRSTPASS MINI INTO THE JOINT PORTAL, THE SPACE AREA WAS NOT TIGHT. WHILE GRABBING THE ROOT OF THE MENISCUS, THE UPPER JAW METAL TIP CAME OUT OF THE JOINT. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED USING ARTHROSCOPIC GRASPERS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627828 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT, DURING A MENISCUS ROOT REPAIR PROCEDURE, THE HOOD OF THE FIRSTPASS MINI LEFT BROKE OFF DURING USE. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW 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 21609909 ↗
• MalfunctionMar 4, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE, ONE (1) UNIT OF THE FIRSTPASS MINI LEFT TRIGGER WAS SQUEEZED TO CLOSE THE JAWS, THE SELF-CAPTURE LOCATED IN THE TOP JAW WAS DISPLACED AND BECOME LODGE IN THE JOINT, ANOTHER (1) UNIT OF THE FISRTPASS MINI LEFT WAS OPENED AND WHEN THE DEVICE ENTERED THE SHOULDER JOINT, THE SELF-CAPTURE DISPLACED WITHOUT CLOSING THE JAWS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, FROM A DIFFERENT LOT NUMBER. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH THE HELP OF GRASPERS. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516244 ↗
• MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPIC SUBSCAPULARIS REPAIR, AS THE SURGEON PROGRESSED THE NEEDLE BY FIRING THE FIRSTPASS MINI, THE CAPTURE WAS DISLODGED FROM THE PASSER. THE FIRSTPASS HAD TO BE REMOVED FROM SHOULDER AND ARTHROSCOPIC GRABBERS WERE USED TO RETRIEVE THE METAL CATCH FROM THE PATIENT. THIS WAS DONE SUCCESSFULLY, NOTHING REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437369 ↗
• MalfunctionFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC STABILIZATION OF RIGHT SHOULDER PROCEDURE, THE SUTURE CAPTURE OF ONE (1) FIRSTPASS MINI LEFT FELL OFF DURING USE, IT FELL OFF INTO THE PATIENT´S SHOULDER AND IT WAS RETRIEVED WITH AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374946 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR, TWO SMALL METAL PIECES OF THE UPPER JAW OF THE FIRSTPASS MINI SUTURE PASSER BROKE, WHEN IT WAS ATTEMPTED TO PASS THE SUTURE THROUGH THE PATIENT'S MENISCUS. THE TWO METAL FRAGMENTS WERE RECOVERED WITH APPROXIMATELY 30 MINUTES OF DELAY TO THE CASE DUE TO THE NEED FOR A C-ARM TO LOCATE THE SECOND PIECE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317812 ↗
• InjuryJan 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FIRSTPASS MINI SUTURE CAPTURE CAME OFF INSIDE THE PATIENT WHEN THE NEEDLE WAS FIRED AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21284946 ↗