T2 1806-1008Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540196576), received between Aug 27, 2015 and Aug 12, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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.

• InjuryAug 12, 2024Failure to Align; Failure to Align

  AS REPORTED: ''"18-YEAR-OLD PATIENT ADMITTED TO THE EMERGENCY ROOM FOLLOWING A HIGH-KINETIC"AVP" FROM HIS SCOOTER WITHOUT A HELMET. DURING THE OPERATION, A T2 FEMORAL NAIL WAS INSERTED USING A NAIL-HOLDER FROM A DIE THROWER, WHICH MALFUNCTIONED WHEN THE DRILL BIT WAS INSERTED IN ORDER TO FIT THE PROXIMAL SYNCHRO LIST. THIS WAS NOT IN FRONT OF THE HOLE. WHEN INSERTING THE NAIL, THE NAIL-HOLDER SHIFTED. AFTER SEVERAL ATTEMPTS AT INSERTION, THE BIT BROKE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961737 ↗
• MalfunctionJan 15, 2024Failure to Align; Naturally Worn; Failure to Align; Naturally Worn

  AS REPORTED: "TARGET DEVICE SHOWS SIGNS OF WEAR. MISDRILLING OCCURRED DURING SURGERY. ASSEMBLY OUTSIDE THE OR - ALL PRODUCTS APPEAR TO WORK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511357 ↗
• MalfunctionSep 3, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT WHEN THE FEMORAL NAIL WAS LOCKED, A FALSE HOLE WAS DRILLED.THE NAIL WAS DIFFICULT TO DETACH FROM THE TARGETING DEVICE AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425612 ↗
• MalfunctionOct 8, 2020Failure to Align; Failure to Align

  FEMUR TARGET DEVICE 1806-1008/1806-1006, MISS DRILLING. STRIKE PLATE 1806-0150 COULD NOT BE SCREWED IN REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 30MIN. NOT LONGER. NO OTHER CONSEQUENCES REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE OP LEAD: THE MISDRILLING OCCURRED AT THE PROXIMAL END THE ISSUE WAS RESOLVED BY USING SECOND TARGETING ARM AND LATER ORDERED NO PATIENT IMPACT, ONLY 30MIN OP TIME INCREASE THE THREADING OF STRIKE PLATE IMPACTED IN A WAY THAT IT CANNOT BE THREADED INTO THE TARGETING ARM ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10653184 ↗
• MalfunctionAug 27, 2015Device Operates Differently Than Expected

  IT IS REPORTED BY THE SENIOR NURSE OF THE HOSPITAL, THAT IF YOU PUT THE METAL GUIDE ARM IN THE CARBON TARGET DEVICE HAS CLEARANCE. EVEN IF YOU CLOSE THE KNURLED NUT, THERE IS NO ACCURACY IN DRILLING. PROCEDURE WAS COMPLETED WITH A FREE HAND LOCKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5035397 ↗