NA 03.168.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982274502), received between Apr 24, 2018 and Mar 3, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE DIRECT MEASUR-DEVICE F/GUIDEWIRES Ø3.2 HAD CONCERNS REGARDING INCONSISTENT MEASUREMENT RESULTS ACROSS DIFFERENT PROCEDURES. THE SURGEON NOTED FRUSTRATION WITH THE DEVICE'S VARYING MEASUREMENT METHODS, WHICH REQUIRE MANUAL ADJUSTMENTS AND CAN LEAD TO CONFUSION AND IMPLANT WASTAGE DURING OPERATIONS. THE REPORTED FAILURE INVOLVED INCORRECT MEASUREMENT FUNCTIONALITY, BUT THERE WAS NO PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497449 ↗
• MalfunctionMar 3, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE DIRECT MEASUR-DEVICE F/GUIDEWIRES Ø3.2 HAD CONCERNS REGARDING INCONSISTENT MEASUREMENT RESULTS ACROSS DIFFERENT PROCEDURES. THE SURGEON NOTED FRUSTRATION WITH THE DEVICE'S VARYING MEASUREMENT METHODS, WHICH REQUIRE MANUAL ADJUSTMENTS AND CAN LEAD TO CONFUSION AND IMPLANT WASTAGE DURING OPERATIONS. THE REPORTED FAILURE INVOLVED INCORRECT MEASUREMENT FUNCTIONALITY, BUT THERE WAS NO PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497443 ↗
• MalfunctionJan 15, 2026Break

  DEPTH GAUGE IS BROKEN AT THE END AND CANNOT PROVIDE ACCURATE MEASUREMENT FOR THE SURGEON. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085803 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED DURING A PROCEDURE THE FEMORAL NECK SYSTEM (FSN) MISSED THE TARGETED COMPLETELY; THE DRILL WAS SET TO 95MM BUT OVER DRILLED TO 100MM. THERE WAS NO IMPACT ON THE PATIENT. IT WAS NOTED THERE WAS RUST ON THE FSN ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701535 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS RUST ON FEMORAL NECK SYSTEM (FNS) ITEMS, AND NEED REPLACING DUE TO FNS DRILL BIT HITTING. THE X2 CANNULATED SCREWS BROKE WHILE INSERTING IN FEMORAL NECK. THE SCREW (03.354.460) BROKE IN FEMORAL NECK. IT SNAPPED IN HALF WHILE INSERTING. THE FNS MISSED THE TARGETER COMPLETELY AND WHENEVER WE SET THE DRILL TO 95MM IT OVER DRILLED TO 100MM. IT KEPT SLIDING FOR SOME REASON. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22651253 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TIP OF DEPTH GAUGE BROKEN OFF. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE DIRECT MEASURING DEVICE 3.2 GUIDE WIRES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18932193 ↗
• MalfunctionApr 26, 2023Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, INSTRUMENT WAS UNABLE TO STERILIZE/ASSEMBLE. CHIPPING AND CRACKING. UNABLE TO USE. NEED REPLACEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DIRECT MEASURING DEVICE 3.2 GUIDE WIRES THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818666 ↗
• MalfunctionJan 26, 2023Incorrect Measurement; Incorrect Measurement

  THERE WAS A 15-MINUTE DELAY IN RELATION TO THE EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT STATUS/OUTCOME WAS SATISFACTORY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246953 ↗
• InjuryMay 20, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING FEMORAL NECK SYSTEM (FNS) PROCEDURE THE SURGEON PENETRATED THE FEMORAL HEAD WITH THE TRIPLE REAMER. THE SURGEON MEASURED IT WITH 87MM AND SET THE REAMER TO 80MM AND THE REAMER STILL PENETRATED TO THE HEAD. THE TRIPLE REAMER WAS ADVANCED FARTHER INTO FEMORAL HEAD THAN INTENDED AND POSSIBILITY EXISTS. THE REAMER WAS POSSIBLY SET TO A LENGTH THAT WAS TOO LONG BUT THAT WAS NOT CONFIRMED AND DID NOT OCCUR AT THE TIME OF THE PROCEDURE. ACCORDING TO THE SURGEON, PATIENT IS PAIN FREE AND WANTS TO WEIGHT BEAR. THE SURGEON IS TREATING THE PATIENT CONSERVATIVELY FOR NOW BUT PLANS TO ALLOW WEIGHT BEARING SOON. THERE WAS NO SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE (PART NUMBER 04.168.290S, LOT UNKNOWN, QUANTITY 1), COMPLETE OPENING DRILL BIT/ REAMER ASSEMBLY (PART NUMBER 03.168.004, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) DIRECT MEASURING DEVICE FOR 3.2MM GUIDE WIRES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10074299 ↗
• MalfunctionNov 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PRE-OPERATIVELY ON (B)(6) 2019 AN INSERT FOR FEMORAL NECK SYSTEM (FNS) INSERTION HANDLE WAS STUCK AND UNRETRIEVABLE FROM A DIRECT MEASURING DEVICE FOR 3.2MM GUIDE WIRES. THE SURGICAL TECHNICIAN INCORRECTLY ASSEMBLED (WITHOUT FORCE) THE PIECES AND THEY BECAME COLD-WELDED TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DIRECT MEASURING DEVICE FOR 3.2MM GUIDE WIRES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9357223 ↗
• InjuryApr 24, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON USED THE FEMORAL NECK SYSTEM TO FIX A FEMORAL NECK FRACTURE. THE DESIRED IMPLANT LENGTH WAS NOT AVAILABLE IN THE HOSPITAL, SO HE DECIDED TO USE A LONGER IMPLANT. THE OPERATING ROOM (OR) NURSE SET UP THE REAMER TO DRILL FOR THE CHOSEN LONGER IMPLANT LENGTH AND NOT FOR THE ORIGINALLY SHORTER MEASURED LENGTH. REAMER WAS STOPPED AFTER HAVING PENETRATED THE HIP JOINT. CONCOMITANT DEVICE: FEMORAL NECK SYSTEM (PART 04.168.100S, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: Injury

  MAUDE report 7454469 ↗