NA 02.226.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982057631), received between Jan 8, 2018 and May 12, 2026 — classified as 4 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 18, 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.

• MalfunctionMay 12, 2026Material Deformation

  IT WAS REPORTED THAT GUIDEWIRE Ø1.6 W/THREAD-TIP W/TROCAR L22 WAS INVOLVED IN AN INTRAOPERATIVE EVENT. DURING THE PLACEMENT OF A SCREW IN THE PROXIMAL TIBIA, TWO GUIDE NEEDLES WERE USED; ONE BROKE AT THE TIP AND REMAINED INSIDE THE PATIENT, WHILE THE OTHER DETERIORATED DURING USE. THE BROKEN FRAGMENT WAS NOT REMOVED, AS REMOVAL WAS CONSIDERED TO POSE A RISK OF INJURY. THE REMAINING FRAGMENTS WERE RETURNED IN THE INSTRUMENT CASE.

  Patient problems: Insufficient Information

  MAUDE report 25149191 ↗
• MalfunctionMay 12, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE Ø1.6 W/THREAD-TIP W/TROCAR L22 WAS INVOLVED IN AN INTRAOPERATIVE EVENT. DURING THE PLACEMENT OF A SCREW IN THE PROXIMAL TIBIA, TWO GUIDE NEEDLES WERE USED; ONE BROKE AT THE TIP AND REMAINED INSIDE THE PATIENT, WHILE THE OTHER DETERIORATED DURING USE. THE BROKEN FRAGMENT WAS NOT REMOVED, AS REMOVAL WAS CONSIDERED TO POSE A RISK OF INJURY. THE REMAINING FRAGMENTS WERE RETURNED IN THE INSTRUMENT CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25149135 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET IT WAS OBSERVED THAT THE THREADED GUIDE WIRE TROCAR WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) 1.6 THREADED GUIDE WIRE TROCAR POINT 220. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528343 ↗
• MalfunctionJan 8, 2018Break; Break

  IT WAS REPORTED THAT DURING A FOOT PROCEDURE, FOUR (4) WIRES BROKE DURING USE. THE SURGEON WAS INSERTING THE FIRST 1.6 MM COMPRESSION WIRE (03.211.420) WITH A DRILL TO IMPLANT A VA (VARIABLE ANGLE) MIDFOOT PLATE, WHEN THE PROXIMAL PORTION OF THE COMPRESSION WIRE BROKE AND WAS EASILY RETRIEVED WITH A NEEDLE DRIVER. THE PLATE WAS INSERTED SUCCESSFULLY. A 1.6 MM THREADED GUIDE WIRE (02.226.000) WAS USED TO IMPLANT ONE OF THE 4.5 MM HEADLESS COMPRESSION SCREWS WHEN IT BROKE AND WAS REMOVED WITH A NEEDLE DRIVER AND ANOTHER GUIDE WIRE WAS USED TO COMPLETE SUCCESSFUL INSERTION OF THE SCREW. ANOTHER 1.6 MM COMPRESSION WIRE (03.211.420) WAS USED TO SUCCESSFULLY PLACE A SECOND VA (VARIABLE ANGLE) MIDFOOT PLATE AND DURING REMOVAL OF THE COMPRESSION WIRE, THE WIRE BROKE DISTALLY. THE BROKEN COMPRESSION WIRE WAS EASILY REMOVED WITH A NEEDLE DRIVER. A 1.6 MM NON-THREADED GUIDE WIRE (02.226.001) WAS USED TO IMPLANT ONE OF THE 4.5 MM HEADLESS COMPRESSION SCREWS FOR THE SECOND PLATE WHEN IT BROKE AND WAS REMOVED WITH A NEEDLE DRIVER AND ANOTHER GUIDE WIRE WAS USED TO COMPLETE SUCCESSFUL INSERTION OF THE SCREW. THERE WAS AN APPROXIMATE FIVE MINUTE SURGICAL DELAY TO RETRIEVE ALL BROKEN PIECES. ROUTIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171645 ↗