NA 03.168.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982274717), received between May 20, 2020 and Oct 29, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON OCTOBER 10, 2025 THE REAMER SLIDES FREELY ON DRILL BIT. OPENED PACKAGE AND ITEM DEFECTIVE AGAIN. THIS IS THE REPLACEMENT FOR THIS PC. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414544 ↗
• MalfunctionAug 11, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE REAMER HEAD SLIDES FREELY ON THE DRILL BIT AND DOES NOT CLICK INTO THE GROVES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778280 ↗
• MalfunctionAug 26, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING ORIF SURGERY FOR FEMORAL NECK FRACTURE, THE SURGEON NOTED THAT THE REAMER USED WAS NOT SHARP ENOUGH. THE REAMER WAS ON LONG-TERM LOAN TO THE HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A COMPLETE OPENING DRILL BIT/ REAMER ASSEMBLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302758 ↗
• MalfunctionDec 28, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2020, A COMPLETE REAMER FOR THE FEMORAL SYSTEM PLACED, SEEMS VERY DULL AND NEED TO REPLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)COMPLETE OPENING DRILL BIT/ REAMER ASSEMBLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11083848 ↗
• 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), DIRECT MEASURING DEVICE FOR 3.2MM GUIDE WIRES (PART NUMBER 03.168.003, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 COMPLETE OPENING DRILL BIT/ REAMER ASSEMBLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10074226 ↗