ORTHOFIX MODULSYSTEM 1 (REF 99-36501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032568861648), received between May 26, 2023 and May 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

23 other recalls cover devices cleared under the same FDA submission (K955848); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 26, 2023Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-36501. BATCH NUMBER: B1845741. HOSPITAL NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6), 2023. BODY PART TO WHICH DEVICE WAS APPLIED: WRIST. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 60 YEARS, FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. EVENT DESCRIPTION: DEVICE BREAKAGE INTO TREATMENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED (PERFORMED ON (B)(6), 2023). A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. PRODUCT IS AVAILABLE FOR RETURN. PRODUCT HAS BEEN PROPERLY CLEANED AND DISINFECTED. ON MAY 24, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: NAME OF THE SURGEON: DR. (B)(6). DATE OF THE BREAKAGE OF THE DEVICE: (B)(6) 2023. CIRCUMSTANCES OF THE FAILURE (WHAT WAS DOING THE PATIENT AT THE MOMENT OF THE DEVICE FAILURE?): NOTHING, THE KNEECAP CAME LOOSE. NO ADVERSE EFFECTS ON PATIENT. DURING THE REVISION SURGERY THE FIXATOR WAS REMOVED, NO OTHER DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008757 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955848. One submission often covers many models, so check the product and lot details in each record.

• Z-0383-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
• Z-0377-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
• Z-0379-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
• Z-0389-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
• Z-0373-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
• Z-0388-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
• Z-0378-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
• Z-0392-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
• Z-0374-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
• Z-0390-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
• Z-0375-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
• Z-0386-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
• Z-0380-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
• Z-0391-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
• Z-0382-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075

…and 8 more.