IBSRecalls & reported problems across all models

We found 8 models of IBS by In2bones in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2020 and Jun 10, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

IBS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 26, 2024Open, Classified

   This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

   Z-1320-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Jan 26, 2024Open, Classified

   This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

   Z-1319-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported IBS problems

IBS models

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

• IBS™ S65 ST175

  Screw, Fixation, Bone
  1 recall0 reports
• IBS™ S65 ST180

  Screw, Fixation, Bone
  1 recall0 reports
• IBS™ G01 00091

  Bit, Surgical
  3 reports
• IBS™ S25 ST028

  Screw, Fixation, Bone
  2 reports
• IBS™ S25 ST022

  Screw, Fixation, Bone
  1 report
• IBS™ S25 ST024

  Screw, Fixation, Bone
  1 report
• IBS™ S35 ST132

  Screw, Fixation, Bone
  1 report
• IBS™ G01 00201

  Screwdriver
  1 report

Recent IBS adverse event reports

The 9 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Use of Device Problem; Insufficient Device Problem Information

  SURGICAL BUNION CORRECTION WITH OSTEOTOMIES. BONE HAD BEEN CUT AND WAS BEING FIXED WITH SURGICAL COMPRESSION SCREWS. AS SCREW WAS INSERTED, SCREW DRIVER TIP SHEARED OFF INSIDE HEAD OF THE SCREW. THE SCREW WAS IN POSITION AND STABLE, THE TIP OF THE SCREWDRIVER WAS RECOVERED AND NO HARM WAS CAUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453422 ↗
• MalfunctionApr 28, 2026Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  AT THE TIME OF MANUALLY INSERTING THE SCREW AND VISUALIZING WITH X-RAYS, IT WAS DETECTED THAT THE SCREW WAS BENT. THEREFORE, IT WAS REMOVED AND THIS DEFECT WAS CONFIRMED. IT WAS REPLACED WITH ANOTHER SCREW OF THE SAME SIZE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012667 ↗
• MalfunctionMar 30, 2026Use of Device Problem

  THE K WIRE CAME OUT OF THE DRILL BIT CANNULA AND BECAME STUCK IN THE CANNULA WINDOW. THE SURGEON STOPPED THE MOTOR ROTATION BEFORE ANY FURTHER DAMAGE OCCURRED. ACCORDING TO THE OPERATOR, THE ADDITIONAL BARS ADDED TO THE DRILL BIT CANNULAS ARE CONSIDERED UNSAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725527 ↗
• MalfunctionMar 20, 2026Use of Device Problem; Insufficient Device Problem Information

  DURING THE PROCEDURE, AN IBS 2.5 SCREW BROKE AT ITS MID SECTION. THE SURGEON INSERTED A GUIDE WIRE FOR AN IPD ARTHRODESIS AND ATTEMPTED TO INSERT THE IBS 2.5 SCREW WITH THE MOTOR DRIVER. THE SCREW TWISTED AROUND THE GUIDE WIRE AND FRACTURED, RESULTING IN AN APPROXIMATE 25 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647073 ↗
• InjurySep 19, 2025Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  DEVICE DESCRIPTION: THE I.B.S®-C COMPRESSION OSTEOSYNTHESIS SCREWS ARE INTENDED FOR THE FIXATION OF ARTHRODESIS, OSTEOTOMIES OR FRACTURES OF LONG OR SHORT BONES OF THE UPPER AND LOWER LIMBS. THE SIZE OF THE CHOSEN SCREW SHOULD BE ADAPTED TO THE SPECIFIC INDICATIONS. EVENT DESCRIPTION: ON (B)(6) 2024, CONMED CUSTOMER SERVICE RECEIVED AN EMAIL FROM A PATIENT REPORTING A SERIOUS INCIDENT INVOLVING AN IMPLANTED ORTHOPEDIC SCREW. THE PATIENT UNDERWENT SURGERY IN (B)(6) 2023 DURING WHICH SIX IBS 2.5-C COMPRESSION SCREWS (DIAMETER 2.5 MM, LENGTH 22 MM, T7) WERE IMPLANTED IN THE TOES. ON (B)(6) 2024, THE PATIENT EXPERIENCED AN EVENT WHILE GETTING INTO BED, DURING WHICH THE MIDDLE TOE BECAME CAUGHT IN A RUG. THIS RESULTED IN THE BENDING OF ONE OF THE IMPLANTED SCREWS AND A DAMAGE OF THE TOE. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE BENT SCREW AND REPLACE IT WITH ALTERNATIVE HARDWARE. THE EMAIL INCLUDED A PHOTO OF THE AFFECTED TOE AND THE BENT SCREW. NOTE: THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

  Patient problems: Fall

  MAUDE report 23096700 ↗
• MalfunctionSep 19, 2025Break; Break

  REFER TO F. FOGAROTTO (FROM THE DISTRIBUTOR COMPANY IN ITALIA) EMAIL DATED ON (B)(6) 2021: « WE HAVE A PROBLEM WITH 1.6MM DRILL REF. (B)(4). IN THE LAST PERIOD THESE DRILLS BREAK AT EACH SURGERY. I THOUGH IT WAS THE SURGEON'S MISTAKE, BUT WHEN I TOLD THEM TO BE CAREFUL, TO FOLLOW THE SURGICAL TECHNIQUE AND POSSIBLY GIVE ME FEEDBACK, THE DRILL BROKE AGAIN. THE DRILLS BROKE IN THE OPENED PART. I DON'T KNOW IF THE PROBLEM LIES IN THE DESIGN BUT I THINK YOU SHOULD GO DEEPER IN THAT. » ADDITIONAL INFORMATION RECEIVED BY E-MAIL ON NOVEMBER 17TH, 2021: « - YES, THE SURGERIES WERE COMPLETED WITHOUT ANY PROBLEMS. - NO, THERE WERE NO PARTICULAR CONDITIONS. 2 DIFFERENT SURGEON, 4 DIFFERENT PATIENTS, DIFFERENT AGES, DIFFERENT INDICATIONS, DIFFERENT IMPLANT SITE. - WE GOT ANOTHER BROKEN DRILL JUST YESTERDAY. HERE THE BATCH NUMBERS: 1809019, 1706211 (X2), 2101108. » "THE BROKEN DRILLS ARE NEW, NO SIGNS OF WEAR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095811 ↗
• MalfunctionSep 19, 2025Break; Break

  EVENT DESCRIPTION: PATIENT INITIALS CHA, MALE, AGED 61 YEARS, WEIGHT 78 KG. DURING THE USE (FOR A RIGHT SUBTALAR ARTHRODESIS), THE CANNULATED DRILL BROKE. IT WAS REMOVED FROM THE PATIENT, WITH THE K-WIRE STUCK INSIDE. NO CLINICAL CONSEQUENCES. THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

  Patient problems: Insufficient Information

  MAUDE report 23093999 ↗
• 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 ↗
• MalfunctionNov 12, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE I.B.S(R) COMPRESSION AND NEUTRALIZATION OSTEOSYNTHESIS SCREWS 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: AN I.B.S COMPRESSION SCREW IS REPORTED TO HAVE BROKEN DURING A BUNION SURGERY (I.E. CORRECTION OF AN HALLUX VALGUS). DESPITE THE REPORTED PROBLEM, THE SURGERY ENDED SUCCESSFULLY WITHOUT ANY CONSEQUENCES FOR THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 10827446 ↗