NA 900.726Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982256362), received between Jan 18, 2019 and Feb 15, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER RECEIVED A BENT THREADED GUIDE WIRE. SURGEON SAID THEY ARE UNABLE TO USE THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 2.8MM THREADED GUIDE WIRE 450MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8344003 ↗
• MalfunctionFeb 14, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE THREADED GUIDE WIRE WAS DEFECTIVE AND BENT. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341425 ↗
• InjuryJan 18, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MAXFRAME FULL RING BROKE ON THE PATIENT'S FRAME WHICH WAS BEING USED TO TREAT A DISTAL TIBIA FRACTURE. THE ORIGINAL IMPLANT PROCEDURE WAS ON (B)(6) 2018. THE BROKEN RING WAS REPLACED ON (B)(6) 2019, WITH A 150MM 5/8 RING AND BRIDGE PLATE. THE PATIENT ALSO BROKE TWO (2) SMOOTH WIRES AND ONE (1) OLIVE WIRES. THE WIRES WERE ALSO REPLACED WITH NEW ONES. IT IS UNKNOWN IT THERE WAS SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) SMOOTH WIRE 2.0MM DIA HALF POINT TIP. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8261155 ↗
• InjuryJan 18, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MAXFRAME FULL RING BROKE ON THE PATIENTS FRAME WHICH WAS BEING USED TO TREAT A DISTAL TIBIA FRACTURE. THE ORIGINAL IMPLANT PROCEDURE WAS ON (B)(6) 2018. THE BROKEN RING WAS REPLACED ON (B)(6) 2019, WITH A 150MM 5/8 RING AND BRIDGE PLATE. THE PATIENT ALSO BROKE TWO (2) SMOOTH WIRES AND ONE (1) OLIVE WIRES. THE WIRES WERE ALSO REPLACED WITH NEW ONES. IT IS UNKNOWN IT THERE WAS SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) SMOOTH WIRE 2.0MM DIA HALF POINT TIP. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8261150 ↗