Henry Schein 570-1047Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10304040081355), received between May 8, 2019 and Mar 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Material Integrity Problem

  ACCORDING TO THE REPORTER, "THE CUSTOMER REPORTS THAT THE SUTURES ARE BREAKING AND FEEL MUCH THINNER THAN A 3-0 SHOULD. THE CUSTOMER STATES THAT THEY HAVE WITNESSED THE SUTURE FILAMENT BREAK WITH VERY LITTLE TENSION WHILE PLACING SUTURES. ALSO FOR THE FIRST TIME THEY HAD A PATIENT WHO CAME IN WITH A SUPERFICIAL RUNNING SUTURE THAT HAD BROKEN. THE END OF THE RUNNING SUTURE LINE WHERE THE FINAL KNOT WAS PLACED WAS GONE AND THE FREE END WAS FRAYED, SUGGESTING BREAKAGE OF THE SUTURE AND NOT A SLIPPED KNOT. SO THEY HAD TO NUMB THE PATIENT AND RESUTURE AS WELL AS SECURE THE FREE END OF THE RUNNING CUTICULAR SUTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571926 ↗
• MalfunctionMar 11, 2026Material Integrity Problem

  ACCORDING TO THE REPORTER, "THE CUSTOMER REPORTS THAT THE SUTURES ARE BREAKING AND FEEL MUCH THINNER THAN A 3-0 SHOULD. THE CUSTOMER STATES THAT THEY HAVE WITNESSED THE SUTURE FILAMENT BREAK WITH VERY LITTLE TENSION WHILE PLACING SUTURES. ALSO FOR THE FIRST TIME THEY HAD A PATIENT WHO CAME IN WITH A SUPERFICIAL RUNNING SUTURE THAT HAD BROKEN. THE END OF THE RUNNING SUTURE LINE WHERE THE FINAL KNOT WAS PLACED WAS GONE AND THE FREE END WAS FRAYED, SUGGESTING BREAKAGE OF THE SUTURE AND NOT A SLIPPED KNOT. SO THEY HAD TO NUMB THE PATIENT AND RESUTURE AS WELL AS SECURE THE FREE END OF THE RUNNING CUTICULAR SUTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571916 ↗
• MalfunctionMar 11, 2026Material Integrity Problem

  ACCORDING TO THE REPORTER, "THE CUSTOMER REPORTS THAT THE SUTURES ARE BREAKING AND FEEL MUCH THINNER THAN A 3-0 SHOULD. THE CUSTOMER STATES THAT THEY HAVE WITNESSED THE SUTURE FILAMENT BREAK WITH VERY LITTLE TENSION WHILE PLACING SUTURES. ALSO FOR THE FIRST TIME THEY HAD A PATIENT WHO CAME IN WITH A SUPERFICIAL RUNNING SUTURE THAT HAD BROKEN. THE END OF THE RUNNING SUTURE LINE WHERE THE FINAL KNOT WAS PLACED WAS GONE AND THE FREE END WAS FRAYED, SUGGESTING BREAKAGE OF THE SUTURE AND NOT A SLIPPED KNOT. SO THEY HAD TO NUMB THE PATIENT AND RESUTURE AS WELL AS SECURE THE FREE END OF THE RUNNING CUTICULAR SUTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571899 ↗
• MalfunctionMay 8, 2019Defective Device

  IT WAS REPORTED THAT PGA SUTURE BREAKING FOR CLOSURE OF ARMS AND LEGS, NEEDLE BENDING AND DIFFICULTY WITH DISPENSING FROM RACETRACK REQUIRING "EXTENDED PRESSURE". (LOT# 180413-53) THESE FAILURES OCCURRED WITH SEVERAL PATIENTS REQUIRING EXTRA SUTURES OR A NEW SUTURE FOR CLOSURE. THE NUMBER OF PATIENTS INVOLVED IS APPROXIMATELY 10 BUT THE EXACT NUMBER IS UNKNOWN. THESE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8593266 ↗