FIRSTPASSRecalls & reported problems across all models

We found 7 models of FIRSTPASS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 689 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2018 and Jun 9, 2026 — classified as 200 injuries, 489 malfunctions.

The most frequently reported specific device problem is “Break” (392 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FIRSTPASS problems

FIRSTPASS models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FIRSTPASS 72290128

  ACCESSORIES,ARTHROSCOPIC
  232 reports
• FIRSTPASS 22-4038

  PASSER
  189 reports
• FirstPass 72290129

  Accessories, arthroscopic
  82 reports
• FirstPass 72290130

  Accessories, arthroscopic
  80 reports
• FIRSTPASS 22-4035

  PASSER
  67 reports
• FIRSTPASS 22-4036

  ACCESSORIES,ARTHROSCOPIC
  34 reports
• FIRSTPASS 22-4039

  PASSER
  5 reports

Recent FIRSTPASS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY WITH MENISCAL REPAIR, WHILE INSERTING ONE (1) FIRSTPASS SUTURE PASSER INTO THE JOINT, THE SUTURE CAPTURE MECHANISM WAS DETACHED. 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 25443997 ↗
• MalfunctionJun 6, 2026Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, UPON PUSHING THROUGH THE MENISCAL TISSUE, THE FIRSTPASS MINI DEFLECTED HITTING THE CAPTURE JAWS AND THE CAPTURE JAWS SUBSEQUENTLY SNAPPED OFF INSIDE THE PATIENT. THE BROKEN PARTS WERE RETRIEVED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419358 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF, WHEN THE JAW OF THE FORCEPS WAS OPENED, THE JAWBONE DETACHED FROM THE FORCEPS AND WAS RECOVERED. NO PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP. THE PATIENT WAS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355780 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, WHEN THE FIRSTPASS BITE THE MENISCUS, THE UPPER JAW BROKE. ALL THE METAL FRAGMENTS WERE REMOVED FROM THE BODY THROUGH A SKIN INCISION. BLEEDING OCCURRED AT THE SITE OF THE INCISION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25345806 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE SUTURE CATCH OF A FIRSTPASS MINI STRAIGHT BROKE INSIDE THE PATIENT¿S KNEE WHILE BACKING OUT THE DEVICE FROM THE JOINT. THE BROKEN PIECE WAS REMOVED WITH AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242652 ↗
• MalfunctionMay 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY WITH ROTATOR CUFF REPAIR, THE SELF CAPTURER OF ONE (1) FIRSTPASS SUTURE PASSER CAME OUT OF THE INSTRUMENT IN THE FIRST BITE ITSELF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202440 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A SMALL METAL COMPONENT OF THE UPPER PART OF THE FIRSTPASS MINI STRAIGHT HAS DISLODGED AND WAS FLOATING INSIDE PATIENT¿S JOINT CAVITY. THAT SMALL METAL PART WAS RETRIEVED AND REMOVED FROM THE PATIENT USING ARTHROSCOPIC GRASPER. NO OTHER PART WAS SEEN IN THE PATIENT¿S JOINT CAVITY, AS CONFIRMED WITH VISUAL INSPECTION OF THE DISLODGED METAL PART AND THE REST OF THE FIRSTPASS MINI DEVICE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175175 ↗
• MalfunctionMay 14, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SUTURE CAPTURE JAW OF A FIRSTPASS MINI BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED WITH THE USE OF X-RAYS AND SURGICAL EXPLORATION. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. 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 25174414 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR, A PIECE OF METAL OF TWO (2) FIRST PASS CAME LOOSE. NO PIECES WERE LEFT INSIDE PATIENTS BODY. 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 25166670 ↗
• MalfunctionMay 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROOT REPAIR, THE TEETH OF A FIRSTPASS FELL OUT OF THE JAWS AFTER GRASPING AN ULTRATAPE. THE TAPE WAS PASSED AND ENTERED THE TEETH, UPON PULL OUT THE TEETH STAYED ATTACHED TO THE TAPE AT THE ROOT OF THE MENISCUS AND THE REST OF THE FIRSTPASS WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145503 ↗
• MalfunctionMay 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE UPPER JAW OF THE FIRSTPASS SUTURE PASSER WAS MISSING. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136172 ↗
• 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 5, 2026Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, ONE (1) FIRSTPASS MINI RIGHT 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 25089579 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, ONE (1) FIRSTPASS MINI SUTURE PASSER WAS NOT CATCHING THE STITCH. WHEN INSPECTING THE TIP OF THE DEVICE, THE "CATCH" PART OF THE TIP WAS MISSING. AFTER, IT WAS NOTICED THAT THE MISSING PIECE WAS ON THE FLOOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. THERE WAS AN UNEXPECTED EXPOSURE TO X-RAY RADIATION. 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 25089488 ↗
• 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 ↗

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