Steel 88862393-89Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521102484), received between Jul 1, 2019 and Apr 29, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, FOUR SUTURE THREADS BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205513 ↗
• MalfunctionApr 29, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, FOUR SUTURE THREADS BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205393 ↗
• MalfunctionApr 29, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, FOUR SUTURE THREADS BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205308 ↗
• MalfunctionMar 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE THREAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992916 ↗
• MalfunctionFeb 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THERE WAS ONE PLUS SUTURE ON THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778380 ↗
• MalfunctionOct 13, 2022Break; Use of Device Problem; Break; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING OPEN THORACOTOMY, AT STERNUM CLOSURE, THE NEEDLE WAS BENDING, MAKING THE SUTURE DIFFICULT TO PASS AND DID NOT HAVE ADEQUATE RESISTANCE. THE NEEDLE THEN BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597106 ↗
• MalfunctionOct 13, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, THE NEEDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15596697 ↗
• MalfunctionOct 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN STERNUM CLOSURE ON AN OPEN CARDIOVASCULAR PROCEDURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT¿S CAVITY. ANOTHER PRODUCT WAS OPENED. THE EVENT RESULTED TO AN EXTENDED SURGICAL TIME TO 30 MINUTES OR MORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12653467 ↗
• MalfunctionJan 8, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A MYOCARDIAL REVASCULARIZATION PROCEDURE, THE SUTURE NEEDLE WAS BROKEN. IT WAS REPORTED THAT WHEN THE WIRE PASSES THROUGH THE STERNUM, THE NEEDLE IS BENT COMPLETELY, THE NEEDLE IS FULLY TWISTED WHILE TRYING TO PASS THROUGH THE BONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9567231 ↗
• MalfunctionJan 6, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOVASCULAR SURGERY, IN THE FIRST ATTEMPT, THE NEEDLE WAS BENT. FOR THE SECOND ATTEMPT, IT WAS ON PART OF THE WIRE IN THE AREA OF THE NEEDLE JUNCTION. WHEN MAKING THE THIRD ATTEMPT, THE NEEDLE BODY LOST ITS SHAPE. THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554864 ↗
• MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE RE-APPROXIMATION OF THE STERNOTOMY ON AN OPEN CORONARY ARTERY BYPASS GRAFTING, THE SUTURE BROKE FROM THE SWAGED END. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751607 ↗
• MalfunctionJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DUPLICATE OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751231 ↗