TRIAX 5150-3-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327072822), received between Apr 10, 2019 and Feb 14, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A IM NAIL TIBIA WITH LIMB LENGTHENING USING T2 TIBIAL NAIL AND MONOTUBE. IT WAS FURTHER REPORTED THAT PATIENT PRESENTED HIMSELF AT CLINIC TODAY ON (B)(6) 2024 AND ALLEGEDLY CLAIMED THE MONOTUBE BROKE. A NEW MONOTUBE WAS APPLIED IN THE CLINIC ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708330 ↗
• InjuryFeb 14, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A IM NAIL TIBIA WITH LIMB LENGTHENING USING T2 TIBIAL NAIL AND MONOTUBE. IT WAS FURTHER REPORTED THAT PATIENT PRESENTED HIMSELF AT CLINIC TODAY ON (B)(6) 2024 AND ALLEGEDLY CLAIMED THE MONOTUBE BROKE. (B)(6) 2024 - UPDATE. A NEW MONOTUBE WAS APPLIED IN CLINIC ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705202 ↗
• MalfunctionNov 9, 2021Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT ON 15/09 A DIAPHYSEAL FRACTURE OF THE RIGHT TIBIA WAS TREATED WITH A TRIAX BLUE FIXATOR. AT THE END OF THE IMPLANTATION, DURING THE CLOSURE OF THE STANDARD CLAMP CODE 5150-3-070 LOT H24962 ((B)(4)) THERE WAS A BREAKAGE OF ONE OF THE TWO NUTS OF THE COVER OF THE CLAMP THAT BLOCK THE CHIPS, WITH CONSEQUENT LOSS OF THE SEAL ON THE CHIPS AND THEREFORE OF THE OBTAINED REDUCTION OF THE FRACTURE. NOT HAVING A SECOND CLAMP TO PERFORM THE REPLACEMENT, THE SURGEON OPTED TO REMOVE AND IMPLANT HOFFMANN 3 FIXATOR. THE PATIENT WILL UNDERGO A FIRST CHECKUP ON MONDAY 27/09 AT WHICH TIME THEY WILL EVALUATE THE STABILITY AND DECIDE WHETHER OR NOT TO CONVERT IT TO UNILATERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779301 ↗
• InjuryJun 29, 2020Device Slipped; Device Slipped

  AS REPORTED: AFTER APPLICATION OF A BLUE TRIAX (FEMUR, CHILD) WITH CARBON ROD AND TWO 4-PIN HOLDERS, A PIN HOLDER ON THE ROD SHIFTED BECAUSE IT WAS LOOSENED AND THE FRACTURE HEALED WITH A MALPOSITION. ADDITIONALLY REPORTED: REVISION SURGERY NECESSARY WITH PLATE OSTEOTOMY.

  Patient problems: Injury; Malunion of Bone

  MAUDE report 10208376 ↗
• MalfunctionApr 10, 2019Break; Fracture; Detachment of Device or Device Component; Fracture

  WHEN ATTACHING THE TUBE TO THE PIN HOLDER, THE PIN HOLDER BROKE OFF.REPLACEMENT WAS AVAILABLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501932 ↗