NA 241.32Recalls & reported problems
Synthes GmbH · ONE-THIRD TUBULAR PLATE WITH COLLAR 2 HOLES/25MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982166791), received between Aug 24, 2023 and Aug 24, 2023 — classified as 6 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem6
Patient problems
- Muscular Rigidity6
- Pain6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR ANKLE FRACTURE WITH ONE-THIRD TUBULAR PLATE COLLAR 2 HOLES/25 MM, CORTEX SCREWS AND CANCELLOUS SCREWS. POST OPERATIVELY IT WAS NOTED THAT PATIENT HAD JOINT RIGIDITY/PAIN. ON AN UNKNOWN DATE THE PATIENT UNDERWENT THE HARDWARE REMOVAL PROCEDURE. THIS REPORT IS FOR ONE-THIRD TUBULAR PLATE WITH COLLAR 2 HOLES/25MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: Muscular Rigidity; Pain
MAUDE report 17615624 ↗InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR ANKLE FRACTURE WITH ONE-THIRD TUBULAR PLATE COLLAR 2 HOLES/25 MM, CORTEX SCREWS AND CANCELLOUS SCREWS. POST OPERATIVELY IT WAS NOTED THAT PATIENT HAD JOINT RIGIDITY/PAIN. ON AN UNKNOWN DATE THE PATIENT UNDERWENT THE HARDWARE REMOVAL PROCEDURE. THIS REPORT IS FOR ONE (1) ONE-THIRD TUBULAR PLATE WITH COLLAR 2 HOLES/25MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: Muscular Rigidity; Pain
MAUDE report 17615295 ↗InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR ANKLE FRACTURE WITH ONE-THIRD TUBULAR PLATE COLLAR 2 HOLES/25 MM AND CORTEX SCREWS. POST OPERATIVELY IT WAS NOTED THAT PATIENT HAD JOINT RIGIDITY/PAIN. ON AN UNKNOWN DATE THE PATIENT UNDERWENT THE HARDWARE REMOVAL PROCEDURE. THIS REPORT IS FOR ONE (1) ONE-THIRD TUBULAR PLATE WITH COLLAR 2 HOLES/25MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Muscular Rigidity; Pain
MAUDE report 17615010 ↗InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR ANKLE FRACTURE WITH ONE-THIRD TUBULAR PLATE COLLAR 2 HOLES/25 MM AND CORTEX SCREWS. POST OPERATIVELY IT WAS NOTED THAT PATIENT HAD JOINT RIGIDITY/PAIN. ON AN UNKNOWN DATE THE PATIENT UNDERWENT THE HARDWARE REMOVAL PROCEDURE. THIS REPORT IS FOR ONE (1) ONE-THIRD TUBULAR PLATE WITH COLLAR 2 HOLES/25MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Muscular Rigidity; Pain
MAUDE report 17614764 ↗InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR ANKLE FRACTURE WITH ONE-THIRD TUBULAR PLATE COLLAR 2 HOLES/25 MM AND CORTEX SCREWS. POST OPERATIVELY IT WAS NOTED THAT PATIENT HAD JOINT RIGIDITY/PAIN. ON AN UNKNOWN DATE THE PATIENT UNDERWENT THE HARDWARE REMOVAL PROCEDURE. THIS REPORT IS FOR ONE (1) ONE-THIRD TUBULAR PLATE WITH COLLAR 2 HOLES/25MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Muscular Rigidity; Pain
MAUDE report 17613769 ↗InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR AN ANKLE FRACTURE WITH A ONE-THIRD TUBULAR PLATE ON AN UNKNOWN DATE. CORTICAL AND CANCELLOUS SCREWS WERE USED FOR FIXATION. AT 28 WEEKS POSTOPERATIVELY, THE PATIENT EXPERIENCED JOINT RIGIDITY AND PAIN, AND UNDERWENT A REOPERATION FOR HARDWARE REMOVAL. THIS REPORT INVOLVES ONE ONE-THIRD TUBULAR PLATE WITH COLLAR 2 HOLES/25MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Muscular Rigidity; Pain
MAUDE report 17612263 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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