NA 241.36Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982166869), received between May 22, 2022 and Dec 3, 2025 — classified as 5 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. 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.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THAT HWR + REVISION RADIUS + ULNA PROCEDURE WAS PERFORMED. REVISION PLATING WAS DONE FOR NON-UNION. (B)(4) IS RELATED TO (B)(4). (B)(4) IS CREATED FOR ADDING ADDITIONAL IPS OF (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23703548 ↗
• 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 WITH A ONE-THIRD TUBULAR PLATE FOR TREATMENT OF AN ANKLE FRACTURE ON AN UNKNOWN DATE. CORTICAL AND CANCELLOUS SCREWS WERE USED FOR FIXATION. AT 24 WEEKS POSTOPERATIVELY, THE PATIENT EXPERIENCED JOINT RIGIDITY AND PAIN AND UNDERWENT HARDWARE REMOVAL SURGERY. UNION HAD BEEN ACHIEVED AT APPROXIMATELY 12 WEEKS. THIS REPORT INVOLVES ONE ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/73MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 17614378 ↗
• 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 WITH A ONE-THIRD TUBULAR PLATE FOR TREATMENT OF AN ANKLE FRACTURE ON AN UNKNOWN DATE. CORTICAL AND CANCELLOUS SCREWS WERE USED FOR FIXATION. AT 20 WEEKS POSTOPERATIVELY, THE PATIENT EXPERIENCED JOINT RIGIDITY AND PAIN, AND UNDERWENT HARDWARE REMOVAL. UNION HAD BEEN ACHIEVED AT APPROXIMATELY 12 WEEKS. THIS REPORT INVOLVES ONE ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/73MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 17613753 ↗
• 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 A 3.5MM ONE THIRD TUBULAR PLATE, UNKNOWN CORTEX SCREWS, SMART PINS AND CANNULATED SCREWS. INTRAOPERATIVELY THERE WAS SEVERE COMMINUTION AND FRAGMENTATION OF FIBULA, PILON VARIANT FRACTURE PATTERN. IT WAS TREATED WITH ADDITIONAL CANNULATED SCREWS IN TIBIA. IT WAS NOTED EXTENDED SURGICAL TIME SECONDARY TO PILON VARIANT ANKLE FRACTURE AND SEVERE COMMINUTION, COMPLICATION NOT RELATED TO SYNTHES DEVICE. THIS REPORT IS FOR ONE (1) ONE-THIRD TUBULAR PL COLLAR 6 HOLES/73. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 17613152 ↗
• InjuryMay 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REMOVAL OF ANKLE PLATES AND HARDWARE OCCURED. THE SHAFT REMAINED IN THE PATIENT AND THE BROKEN HEAD WAS REMOVED FROM THE PATIENT. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR (1) ONE-THIRD TUBULAR PL COLLAR 6 HOLES/73. THIS IS REPORT 3 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14467173 ↗