NA 02.207.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982051721), received between Feb 12, 2019 and Nov 7, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2023Break; Break

  IT WAS REPORTED THAT ON 18-OCTOBER-2023 DURING AN ORIF OF THE SACROILIAC JOINT ONE OF THE GUIDE WIRES BROKE DURING WIRE REMOVAL. ON THE LEFT SIDE, A SCREW WAS PLACED IN AT THE JUNCTION OF THE SCREW HEAD ENTRY POINT AND THE SCREW HAD TO BE REMOVED FOR THE WIRE TO BE REMOVED. THIS CREATED APPROXIMATELY 30 MINUTES OF SURGICAL DELAY. ON THE RIGHT SIDE, THE SCREWDRIVER TIP BROKE WHILE INSERTING A SCREW. NOT ALL FRAGMENTS GENERATED WERE ABLE TO BE REMOVED. IT WAS SUSPECTED THAT TWO SCREWS FROM OPPOSITE SIDES INTERFERED WITH ONE ANOTHER. NO WIRE FRAGMENTS WERE LEFT BEHIND. THIS REPORT IS FOR A 2.8MM GUIDE WIRE WITH FLUTES 450MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083401 ↗
• MalfunctionSep 24, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS FURTHER REPORTED THAT IT WAS THE FEMORAL HEAD SLIP PROCEDURE AND THE BROKEN FRAGMENT OF THE GUIDE WIRE WAS REMAINED IN THE NECK OF THE FEMUR, PROXIMAL TO THE HIP. IT WAS ALSO REPORTED THAT SURGEON DIDN'T HAVE ENOUGH EDGE SO HE HAD TO DO MORE FORCE TO DRILL. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF THIRTY (30) MINUTES.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9109116 ↗
• MalfunctionAug 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE) PROCEDURE ON AN UNKNOWN DATE, THE SURGEON ENCOUNTERED AN ISSUE WITH THE DRILL BIT WHERE IT WAS BINDING AND PUSHING ON THE GUIDE WIRE ALONG WITH THE DRILL BIT. THE LEFT HIP WAS DONE FIRST. THE SURGEON REPORTED THAT THE GUIDEWIRE PUSHED THE FEMORAL HEAD AND INTO THE ACETABULAR AREA; ALTHOUGH, IT WAS NOT SURE IF THE ACETABULUM WAS COMPLETELY PENETRATED. IT WAS MENTIONED THAT THE SAME DRILL BIT WAS PROBLEMATIC ON THE CONTRA LATERAL SIDE; THE SURGEON HAD TO BE EXTRA CAREFUL TO ENSURE THAT THE SAME ISSUE WOULD NOT OCCUR. IT WAS NOTED THAT DURING THE PROCEDURE FOUR (4) GUIDE WIRES BENT; HOWEVER ONLY ONE OF THE WIRES PENETRATED THE ACETABULUM ON THE RIGHT HIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED DESPITE THE DRILL BIT ISSUE. THERE WAS A THIRTY TO FORTY-FIVE (30-45) MINUTE SURGICAL DELAY REPORTED. CONCOMITANT DEVICE REPORTED: SCFE SCREW (PART 02.207.626, LOT UNKNOWN, QUANTITY 1), SCFE SCREW (PART 02.207.625, LOT UNKNOWN, QUANTITY 1), OVAL WASHER (PART 02.207.637, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A GUIDE WIRE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944891 ↗
• MalfunctionAug 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE) PROCEDURE ON AN UNKNOWN DATE, THE SURGEON ENCOUNTERED AN ISSUE WITH THE DRILL BIT WHERE IT WAS BINDING AND PUSHING ON THE GUIDE WIRE ALONG WITH THE DRILL BIT. THE LEFT HIP WAS DONE FIRST. THE SURGEON REPORTED THAT THE GUIDEWIRE PUSHED THE FEMORAL HEAD AND INTO THE ACETABULAR AREA; ALTHOUGH, IT WAS NOT SURE IF THE ACETABULUM WAS COMPLETELY PENETRATED. IT WAS MENTIONED THAT THE SAME DRILL BIT WAS PROBLEMATIC ON THE CONTRA LATERAL SIDE; THE SURGEON HAD TO BE EXTRA CAREFUL TO ENSURE THAT THE SAME ISSUE WOULD NOT OCCUR. IT WAS NOTED THAT DURING THE PROCEDURE FOUR (4) GUIDE WIRES BENT; HOWEVER ONLY ONE OF THE WIRES PENETRATED THE ACETABULUM ON THE RIGHT HIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED DESPITE THE DRILL BIT ISSUE. THERE WAS A THIRTY TO FORTY-FIVE (30-45) MINUTE SURGICAL DELAY REPORTED. CONCOMITANT DEVICE REPORTED: SCFE SCREW (PART 02.207.626, LOT UNKNOWN, QUANTITY 1); SCFE SCREW (PART 02.207.625, LOT UNKNOWN, QUANTITY 1); OVAL WASHER (PART 02.207.637, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A GUIDE WIRE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944869 ↗
• MalfunctionAug 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE) PROCEDURE ON AN UNKNOWN DATE, THE SURGEON ENCOUNTERED AN ISSUE WITH THE DRILL BIT WHERE IT WAS BINDING AND PUSHING ON THE GUIDE WIRE ALONG WITH THE DRILL BIT. THE LEFT HIP WAS DONE FIRST. THE SURGEON REPORTED THAT THE GUIDEWIRE PUSHED THE FEMORAL HEAD AND INTO THE ACETABULAR AREA; ALTHOUGH, IT WAS NOT SURE IF THE ACETABULUM WAS COMPLETELY PENETRATED. IT WAS MENTIONED THAT THE SAME DRILL BIT WAS PROBLEMATIC ON THE CONTRA LATERAL SIDE; THE SURGEON HAD TO BE EXTRA CAREFUL TO ENSURE THAT THE SAME ISSUE WOULD NOT OCCUR. IT WAS NOTED THAT DURING THE PROCEDURE FOUR (4) GUIDE WIRES BENT; HOWEVER ONLY ONE OF THE WIRES PENETRATED THE ACETABULUM ON THE RIGHT HIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED DESPITE THE DRILL BIT ISSUE. THERE WAS A THIRTY TO FORTY-FIVE (30-45) MINUTE SURGICAL DELAY REPORTED. CONCOMITANT DEVICE REPORTED: SCFE SCREW (PART 02.207.626, LOT UNKNOWN, QUANTITY 1), SCFE SCREW (PART 02.207.625, LOT UNKNOWN, QUANTITY 1), OVAL WASHER (PART 02.207.637, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A GUIDE WIRE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944839 ↗
• InjuryAug 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE) PROCEDURE ON AN UNKNOWN DATE, THE SURGEON ENCOUNTERED AN ISSUE WITH THE DRILL BIT WHERE IT WAS BINDING AND PUSHING ON THE GUIDE WIRE ALONG WITH THE DRILL BIT. THE LEFT HIP WAS DONE FIRST. THE SURGEON REPORTED THAT THE GUIDEWIRE PUSHED THE FEMORAL HEAD AND INTO THE ACETABULAR AREA; ALTHOUGH, IT WAS NOT SURE IF THE ACETABULUM WAS COMPLETELY PENETRATED. IT WAS MENTIONED THAT THE SAME DRILL BIT WAS PROBLEMATIC ON THE CONTRA LATERAL SIDE; THE SURGEON HAD TO BE EXTRA CAREFUL TO ENSURE THAT THE SAME ISSUE WOULD NOT OCCUR. IT WAS NOTED THAT DURING THE PROCEDURE FOUR (4) GUIDE WIRES BENT; HOWEVER ONLY ONE OF THE WIRES PENETRATED THE ACETABULUM ON THE RIGHT HIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED DESPITE THE DRILL BIT ISSUE. THERE WAS A THIRTY TO FORTY-FIVE (30-45) MINUTE SURGICAL DELAY REPORTED. CONCOMITANT DEVICE REPORTED: SCFE SCREW (PART 02.207.626, LOT UNKNOWN, QUANTITY 1), SCFE SCREW (PART 02.207.625, LOT UNKNOWN, QUANTITY 1), OVAL WASHER (PART 02.207.637, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A GUIDE WIRE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 8944812 ↗
• MalfunctionMay 31, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GUIDE WIRE WITH FLUTES WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 MM GUIDE WIRE WITH FLUTES 450 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8660228 ↗
• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THAT ON AN (B)(6) 2019, THE GUIDE WIRE WITH FLUTES WAS DISCOVERED TO HAVE A BROKEN TIP DURING A ROUTINE INSPECTION OF THE SET. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8MM GUIDE WIRE WITH FLUTES 450MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8331125 ↗