NA 310.243Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982186300), received between Mar 13, 2018 and Jan 29, 2026 — classified as 1 injury, 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. 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.

• MalfunctionJan 29, 2026Failure to Cut

  DURING THE SURGERY, IT WAS EVIDENT THAT THE TIPS OF THE DRILL BITS WERE DULL. THE SPECIALIST EXPRESSED DISSATISFACTION DUE TO THE DULLNESS OF THE DRILL BITS, WHICH PROLONGED THE SURGERY BY TEN MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215385 ↗
• MalfunctionMay 18, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: DURING SURGERY ON (B)(6) 2022, THE GUIDE WIRE COLLIDED WITH A FEMUR NAIL, CAUSING THE TIP OF THE WIRE TO DEFORM AND TWIST. THE FEMUR NAIL WAS IMPLANTED IN A PREVIOUS SURGERY. THIS REPORT IS FOR A GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431330 ↗
• MalfunctionMay 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY, THE DRILL BIT IS PART AT THE TIME OF DRILLING. THIS REPORT IS FOR ONE (1) GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401672 ↗
• MalfunctionDec 22, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY IT WAS NOTICED THAT ALL INSTRUMENTS ARE NOT PERFORMING PROPERLY. THE DISTAL TIP OF THE GUIDE WIRE WAS STRIPPED/DEFORMED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 2.5MM DRILL TIP GUIDE WIRE 200MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059776 ↗
• MalfunctionDec 22, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY IT WAS NOTICED THAT ALL INSTRUMENTS ARE NOT PERFORMING PROPERLY. THE DISTAL TIP OF THE GUIDE WIRE WAS STRIPPED/ DEFORMED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 2.5MM DRILL TIP GUIDE WIRE 200MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059769 ↗
• MalfunctionMar 1, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE 2.5MM DRILL TIP GUIDE WIRE WAS DAMAGED. THERE WAS NO PATIENT CONSEQUENCE. THE DEVICE WAS NO USED IN SURGERY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.5MM DRILL TIP GUIDE WIRE 200MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392785 ↗
• InjuryJul 31, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, 2.5MM DRILL TIP GUIDE WIRE BROKE OFF DURING THE 4.5 / 5.0 PROXIMAL FEMORAL PLATE IMPLANTATION. DURING THE PLATE IMPLANTATION SURGEON PLACED THE 2.5MM DRILL TIP GUIDE WIRE THROUGH THE PROXIMAL HOLE OF THE PLATE AND UNDER DIRECT VISION OF IMAGE INTENSIFIER IT WAS NOTICED THAT THE GUIDE WIRE RUPTURED BETWEEN THE NECK AND THE GREATER TROCHANTER OF THE FEMUR OF THE PATIENT WHEN ATTEMPTING TO REARRANGE IT WITH THE MOTOR, WHICH MADE A SUDDEN MOVEMENT AND BROKE THE GUIDE WIRE. PER SURGEON BROKEN PIECE IS OUT OF REACH FOR EXTRACTION. PER SURGEON THERE WILL BE NO HEALTH RISK TO THE PATIENT. NO OTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN 4.5 / 5.0 PROXIMAL FEMORAL PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.5MM DRILL TIP GUIDE WIRE 200MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8848291 ↗
• MalfunctionMar 13, 2018Bent; Bent

  IT WAS REPORTED THAT A GUIDE WIRE WAS BENT AND STUCK BETWEEN THE LID AND THE CASE IN AN EVALUATION SET. THERE IS NO PATIENT OR PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7336570 ↗