NA 02.226.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982057655), received between Dec 26, 2017 and Jan 4, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2024Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ANKLE JOINT FIXATION WITH THE GUIDE WIRES FOR THE DISTAL TIBIA. WHEN THE SURGEON OPENED THE PACKAGE, THE GUIDE WIRE WAS DEFORMED. ALTHOUGH A NEW PACKAGE WAS OPENED, THE GUIDE WIRE WAS ALSO DEFORMED. BOTH OUTER BOXES HAD SCRATCHES ON THEM. THE THIRD GUIDE WIRE WAS USED FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDEWIRE ø1.6 L220 SST THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442981 ↗
• MalfunctionJan 4, 2024Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ANKLE JOINT FIXATION WITH THE GUIDE WIRES FOR THE DISTAL TIBIA. WHEN THE SURGEON OPENED THE PACKAGE, THE GUIDE WIRE WAS DEFORMED. ALTHOUGH A NEW PACKAGE WAS OPENED, THE GUIDE WIRE WAS ALSO DEFORMED. BOTH OUTER BOXES HAD SCRATCHES ON THEM. THE THIRD GUIDE WIRE WAS USED FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDEWIRE ø1.6 L220 SST. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442973 ↗
• MalfunctionSep 15, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH GUIDE WIRE. WHEN THE GUIDE WIRE IN QUESTION WAS OPENED, IT WAS BENT. SO, A NEW GUIDE WIRE WAS OPENED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756726 ↗
• MalfunctionJan 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY, A CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED ALONG WITH THE HEADLESS COMPRESSION SCREW AND FIVE (5) NON-THREADED GUIDE WIRES WERE BENT PRIOR TO INSERTION. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127340 ↗
• MalfunctionJan 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY, A CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED ALONG WITH THE HEADLESS COMPRESSION SCREW AND FIVE (5) NON-THREADED GUIDE WIRES WERE BENT PRIOR TO INSERTION. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127330 ↗
• MalfunctionJan 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY, A CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED ALONG WITH THE HEADLESS COMPRESSION SCREW AND FIVE NON-THREADED GUIDE WIRES WERE BENT PRIOR TO INSERTION. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVAIT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY, A CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED ALONG WITH THE HEADLESS COMPRESSION SCREW AND FIVE (5) NON-THREADED GUIDE WIRES WERE BENT PRIOR TO INSERTION. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127310 ↗
• MalfunctionJan 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY, A CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED ALONG WITH THE HEADLESS COMPRESSION SCREW AND FIVE (5) NON-THREADED GUIDE WIRES WERE BENT PRIOR TO INSERTION. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127283 ↗
• MalfunctionJan 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY, A CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED ALONG WITH THE HEADLESS COMPRESSION SCREW AND FIVE (5) NON-THREADED GUIDE WIRES WERE BENT PRIOR TO INSERTION. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127125 ↗
• 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 7171647 ↗
• MalfunctionDec 26, 2017Break; Break

  IT WAS REPORTED DURING AN INITIAL MID-FOOT PROCEDURE ON (B)(6) 2017 A KIRSCHNER WIRE BROKE INTRAOPERATIVELY. THE WIRE BROKE WHILE THE SURGEON WAS DRILLING FOR A CANNULATED SCREW PLACEMENT IN THE FOOT. THE WIRE WAS EMBEDDED IN THE PATIENT BONE AND NO ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENTS. NO SURGICAL DELAY OCCURRED. THE SURGEON CONTINUED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS STABLE POSTOPERATIVELY. CONCOMITANT DEVICE REPORTED: DRILL BIT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7145973 ↗