NA 1806-6171Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540510075), received between Aug 7, 2018 and Sep 10, 2024 — classified as 3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE STRYKER EXTRACTION SIEVE THREADED ATTACHMENT WITH THE REF: (B)(4) WAS BROKEN OFF AND COULD NO LONGER BE USED. THIS WAS NOTICED DURING DEVICE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179316 ↗
• MalfunctionJul 13, 2020Material Twisted/Bent; Material Twisted/Bent

  AFTER REMOVING T2GTN, THE END CAP COULD BE REMOVED BY THE USUAL PROCEDURE, BUT THE SURGEON COULD NOT PULL THE NAIL OUT WITH SOFT TISSUE OR CALLUS, AND TRIED TO REMOVE IT WITH THE CONICAL EXTRACTOR (18066171), BUT THE INSERTED ANGLE SEEMED BAD, AND THE TIP WAS DAMAGED. IN THIS CASE, IT WAS REPLACED WITH T2ALPHAGT AT THE PSEUDO JOINT AFTER T2GTN. AFTER REMOVING THE NAIL, REAMING WAS DONE UP TO 15 MM AND INSERT A 14 MM DIAMETER NAIL. HOWEVER, THE SURGEON ATTEMPTED TO REMOVE IT IN THE MIDDLE BECAUSE THE NAIL COULD NOT BE INSERTED. THE SURGEON TRIED TO ATTACH THE UNIVERSAL ROD AND REMOVE THE NAIL, BUT THE NAIL DID NOT COME OUT AT ALL, AND WHEN THE SURGEON WAS OPERATING IT WITH A HAMMER SEVERAL TIMES, THE SURGEON BROKE THE THREAD PART OF THE UNIVERSAL ROD. THE SURGEON COULDN'T PULL OUT THE NAIL, SO HE COULD EXPAND THE INSIDE OF THE MEDULLARY CANAL WITH K-WIRE, AND MANAGED TO PULL OUT THE NAIL USING THE UNIVERSAL ROD AT THE HOSPITAL. THE, HE WAS ABLE TO REAM UP TO 16 MM AGAIN AND INSERT A NAIL. WHEN THE STRIKE PLATE WAS ATTACHED TO THE TIP OF THE UNIVERSAL ROD, THE TIP OF THE UNIVERSAL ROD WAS DAMAGED AND LEFT INSIDE THE STRIKE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10268041 ↗
• MalfunctionAug 7, 2018Break; Collapse

  THE PATIENT UNDERWENT T2 TIBIA SURGERY ON (B)(6) 2017, AND THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2018. WHEN THE END CAP WAS ATTEMPTED TO BE REMOVED WITH A DRIVER BUT THE HEAD OF THE END CAP COLLAPSED. THEREFORE, THE CONICAL EXTRACTOR WAS USED TO REMOVED THE END CAP BUT THE TIP OF THE EXTRACTOR BROKE IN THE HEAD OF THE END CAP, AND THE BROKEN TIP COULD NOT BE REMOVED. THE SURGEON TRIED TO REMOVED THE END CAP BUT IT COMPLETELY STUCK IN THE NAIL, SO ONLY LOCKING SCREWS WERE REMOVED AND THE NAIL REMOVAL SURGERY WAS GAVE UP. BROKEN FRAGMENT REMAINING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756163 ↗