IBS™ S35 ST132Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760225711811), received between Sep 15, 2023 and Sep 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K131920); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE I.B.S.¿ COMPRESSION AND NEUTRALIZATION OSTEOSYNTHESIS SCREWS ARE USED IN FOREFOOT ORTTHOPAEDIC SURGERY AND ARE INTENDED FOR: - THE FIXATION OF ARTHRODESIS, OSTEOTOMIES OR FRACTURES OF LONG OR SHORT BONES OF THE UPPER AND LOWER LIMBS, - OSTEOSYNTHESIS REQUIRING A MONO OR BICORTICAL COMPRESSION. EVENT DESCRIPTION : INITIAL INFORMATION REPORTED BY A DISTRIBUTOR ON (B)(6), 2022: "THEY REALIZED THAT THE SCREW LOCATION WAS TOO DORSAL AND LOOKED BENT AS WELL ON X-RAY. ONCE THEY GOT THE SCREW OUT, THE BOTTOM OF SCREW BROKE OFF. I ADDED IMAGES THAT I TOOK THAT DAY OF THE DRIVER THAT BROKE, THE SCREW ONCE IT CAME OUT, AND THE X-RAY OF IBS SCREWS WHEN FIRST IMPLANTED. SURGEON ENDED UP USING TWO 4.0 SCREWS TO COMPLETE THE CASE (AFTER TAKING OUT IBS SCREWS) AND WAS CONTENT WITH SCREW PLACEMENT." THE SURGERY ENDED SUCCESSFULLY AFTER A SIGNIFICANT DELAY IN SURGERY DURATION; ANY CONSEQUENCES FOR THE PATIENT. IT IS CONSIDERED THAT IF THE EVENT WERE TO HAPPEN AGAIN IT COULD CAUSE A SERIOUS INJURY TO THE PATIENT AND IS THUS TO BE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131920. One submission often covers many models, so check the product and lot details in each record.

• Z-1319-2024 · Jan 26, 2024 · Open, Classified
  I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
• Z-1320-2024 · Jan 26, 2024 · Open, Classified
  I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
• Z-0397-2016 · Nov 18, 2015 · Terminated
  IBS - Osteosynthesis screws for bone fixation Model S25 ST014.