NA 1806-0050SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540195852), received between Apr 11, 2017 and Oct 5, 2021 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2021Break

  K-WIRE BROKE WHILE IN PATIENT IN OPERATIVE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576054 ↗
• MalfunctionJun 17, 2021Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  AS REPORTED: "IN THE PROCEDURE OF THE T2 FEMUR NAIL, DUE TO THE COMPLEXITY OF THE FRACTURE, GUIDE PINS ARE PASSED, AND THE GUIDE NEEDLE IS PASSED 18060050S FOR THE PLACEMENT OF THE SCREW, THE RESIDENT CUTS THE PINS THAT HAVE BEEN PASSED TO REDUCE THE FRACTURE AND BETWEEN THEM CUT THE GUIDE NEEDLE THROUGH ERROR, SO THE SURGEON DECIDED TO LEAVE THE GUIDE NEEDLE TO HELP IN REDUCING THE FRACTURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 12018162 ↗
• MalfunctionNov 6, 2020Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT AS HE WAS USING A K-WIRE DURING THE CASE, HE NOTICED SHARDS OF METAL - 'SWARF' ON THE DRAPES. NO METAL WAS SEEN IN THE PATIENT. THE ROUTINE POST OP X-RAY SHOWED NO EVIDENCE OF SHARDS IN THE PATIENT. IT HAPPENED DURING ENTRY POINT OF A TIBIAL NAIL. WAS A SUPRA-PATELLA APPROACH TO THE NAIL. THE PROCEDURE WAS COMPLETED USING THE SAME WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10805388 ↗
• MalfunctionFeb 28, 2020Break; Break

  THE CUSTOMER REPORTED THAT DURING A SUPRACONDYLAR NAIL CASE, THE SURGEON WAS DRILLING THROUGH THE JIG INTO ONE OF THE HOLES. THE DRILL BROKE AND THE TIP REMAINED INSIDE THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE. THERE WAS A 3 MINUTE DELAY TO SURGERY. THE PATIENT WAS YOUNG WITH HARD BONE. IT IS NOT KNOWN IF THE SURGEON WAS DRILLING AT AN ANGLE. OR PUTTING PRESSURE ON THE DRILL OR IF THE DRILL TOUCHED THE JIG / OTHER METAL ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772383 ↗
• MalfunctionMay 22, 2019Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT ANKLE, THE DEVICE WAS NOT OPENED AS THE OUTER STERILE PACKAGING WAS NOTED TO HAVE A HOLE IN IT. THE HOLE WAS SEEN WITHOUT OPENING THE OUTER PACKAGING. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS AVAILABLE FOR IMMEDIATE USE. SURGERY WAS COMPLETED WITH NO DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631565 ↗
• MalfunctionJan 18, 2019Device Contamination with Chemical or Other Material

  IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (BUG) IN BLISTER. NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, DELAY OR MEDICAL INTERVENTION.

  Patient problems: No Patient Involvement

  MAUDE report 8262022 ↗
• MalfunctionApr 11, 2017Device Contamination with Chemical or Other Material

  IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR) IN BLISTER. THIS EVENT WAS FOUND ON 1 OF 35 UNITS. NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, DELAY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6483759 ↗