ASNIS 604660SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540089908), received between Oct 29, 2025 and Oct 29, 2025 — classified as 4 injuries, 1 malfunction.

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

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Fracture; Fracture

  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. 40-20903S BATCH 1000591836. SEVERAL ORTHOPEDIC CONSULTATIONS, INCLUDING ON (B)(60 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; (PLEASE REFER TO COMPLAINTS (B)(4). DURING EXPLANTATION OF THE MATERIAL INCOMPLETE, A SCREW BROKE IN THE BONE OF THE MALLEOLUS DURING ITS EXTRACTION. A PIECE OF THE SCREW COULD NOT BE REMOVED AND REMAINS IN THE TISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23418095 ↗
• 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. 40-20903S 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 23417937 ↗
• 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 PI (B)(4)).

  Patient problems: Medical device site infection

  MAUDE report 23417932 ↗
• 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. 40-20903S 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 10/02/2025, 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 (B)(4).

  Patient problems: Medical device site infection

  MAUDE report 23417574 ↗
• 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. 40-20903S, 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 (B)(4)).

  Patient problems: Medical device site infection

  MAUDE report 23417537 ↗