NA 40-20903SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540604613), received between Sep 14, 2015 and Oct 29, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT: "PATIENT OPERATED ON (B)(6) 2024 FOR A BIMALLEOLAR FRACTURE WITH INSERTION OF TWO STRYKER SCREWS REF. 604660S BATCH K31308 AND ONE PLATE REF. (B)(4). BATCH 1000591836. SEVERAL ORTHOPEDIC CONSULTATIONS, INCLUDING ON (B)(6) 2024 "MATERIAL VISIBLE TO THE NAKED EYE AND INFECTION ON MATERIAL" PROPOSAL TO REMOVE THE MATERIAL; LAST CONSULTATION ON (B)(6) 2025 WITH SCHEDULING OF OUTPATIENT REMOVAL (INFECTION WAS CONTROLLED BETWEEN THE PREVIOUS CONSULTATION AND THE LAST ONE WITH TRACEABILITY OF COMPLEX DRESSINGS). (PLEASE REFER TO COMPLAINTS (B)(4)). ON (B)(6) 2025, REMOVAL IN DAY HOSPITAL IN ACCORDANCE WITH DECISION. DURING EXPLANTATION OF THE MATERIAL INCOMPLETE, A SCREW BROKE IN THE BONE OF THE MALLEOLUS DURING ITS EXTRACTION. (PLEASE REFER TO COMPLAINT (B)(4)).

  Patient problems: Medical device site infection

  MAUDE report 23417935 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT: "PATIENT OPERATED ON (B)(6) 2024 FOR A BIMALLEOLAR FRACTURE WITH INSERTION OF TWO STRYKER SCREWS REF. (B)(4) BATCH K31308 AND ONE PLATE REF. (B)(4) BATCH 1000591836. SEVERAL ORTHOPEDIC CONSULTATIONS, INCLUDING ON (B)(6) 2024 "MATERIAL VISIBLE TO THE NAKED EYE AND INFECTION ON MATERIAL" PROPOSAL TO REMOVE THE MATERIAL; LAST CONSULTATION ON (B)(6) 2025 WITH SCHEDULING OF OUTPATIENT REMOVAL (INFECTION WAS CONTROLLED BETWEEN THE PREVIOUS CONSULTATION AND THE LAST ONE WITH TRACEABILITY OF COMPLEX DRESSINGS). ON (B)(6) 2025, REMOVAL IN DAY HOSPITAL IN ACCORDANCE WITH DECISION; (PLEASE REFER TO COMPLAINTS (B)(4)). DURING EXPLANTATION OF THE MATERIAL INCOMPLETE, A SCREW BROKE IN THE BONE OF THE MALLEOLUS DURING ITS EXTRACTION. (PLEASE REFER TO PI (B)(4)).

  Patient problems: Medical device site infection

  MAUDE report 23417732 ↗
• MalfunctionMar 12, 2024Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn

  AS REPORTED: "ORIF WAS PERFORMED FOR LEFT DISTAL FIBULA FRACTURE (PRIMARY SURGERY DATE IS UNKNOWN). DURING THE BARIATRIC FIBULA EXPLANTING SURGERY ON (B)(6) 2024, SOMETHING LIKE METAL SHAVINGS CAME OUT WHILE REMOVING THE BONE SURROUNDING THE SCREW HEAD." NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18883892 ↗
• InjuryNov 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON 28 APR 2021 THE PATIENT HAD PRIMARY SURGERY AND A FIBULAR PLATE AND SCREWS WERE INSERTED. THE PLATE AND SCREWS WERE EXTRACTED ON 01 JUN 2022 DUE TO COMPLETED BONE UNION. ON (B)(6) 2023 THE PATIENT WAS SEEN IN THE OUTPATIENT CLINIC BECAUSE OF THE APPEARANCE OF AN INFLAMMATORY REACTION. THE AFFECTED AREA HAD STARTED TO SWELL A LITTLE AROUND JANUARY AND THEN THE BULGE IN THE AFFECTED AREA GREW LARGER. A METAL SHARD-LIKE SUBSTANCE WAS REMOVED FROM THE SURGICAL WOUND THROUGH A SMALL INCISION.

  Patient problems: Failure of Implant; Foreign Body In Patient; Inflammation; Swelling/ Edema

  MAUDE report 18219238 ↗
• MalfunctionSep 10, 2018Appropriate Device Problem Term/Code Not Available

  THREE VARIAX DISTAL FIBRA PLATE WERE USED, BUT LOCKING FAILURE OCCURRED AT ONE DISTAL SCREW HOLE. USED A NEW SCREW, BUT DID NOT LOCK IT AS WELL. IT WAS FIXED USING ANOTHER SCREW HOLE. THE PLATE IS NOT BENT AND IT IS NOT FORCIBLY DRILLED BY THE POLY AXIAL DIRECTION. IT DID NOT LOCK EVEN WITH THE SCREW OF ACTUAL MEASUREMENT BY DRILLING OF MONOCORTICAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7861906 ↗
• MalfunctionSep 14, 2015Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DISTAL HOLE OF DISTAL FIBULA PLATE AND THE SCREW COULD NOT BE LOCKED. SPARE SCREW WAS USED, BUT COULD NOT BE LOCKED WITH THE SAME HOLE. THE DISTAL HOLE WAS NOT USED AND ANOTHER HOLE WAS USED INSTEAD OF IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5075672 ↗