NA 2125-00-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10603295087878), received between Mar 22, 2018 and Sep 10, 2026 — classified as 130 malfunctions.

The most frequently reported specific device problem is “Break” (54 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 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721860 ↗
• MalfunctionJun 1, 2026Material Deformation

  IT WAS REPORTED THAT TIP OF THE DEVICE WAS BENT. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350615 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT THE CORK SCREW BROKE OFF AT THE CONNECTION POINT OF THE QUICK CONNECT TO THE DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347297 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. THE MODULAR HEAD BALL REMOVER WOULD NOT SEAT PROPERLY IN THE POWER TOOL WITH THE HUDSON ADAPTER. ALL OTHER TOOLS WOULD LATCH PROPERLY. THE MODIFIED HUDSON ATTACHMENT DID WORK AND WAS UTILIZED AS A TEMPORARY FIX. NO DELAY IN CASE, NO HARM TO PATIENT, AND NO PIECES BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163902 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE CORKSCREW BROKE OFF AND ALL PIECES WERE RETRIEVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159352 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CORKSCREW BROKE WHERE IT ATTACHES TO THE T-HANDLE. IT WAS REPORTED THAT THERE WAS NO HARM DONE TO THE PATIENT AND NO DELAYS. IT WAS REPORTED THAT THE SURGEON USED VICE GRIPS TO PULL OUT. IT WAS REPORTED THAT ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008681 ↗
• MalfunctionApr 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT POWER CORKSCREW IS VERY DULL ON THE TIP. IT DOES NOT ENGAGE WITH THE FEMORAL HEAD EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997611 ↗
• MalfunctionApr 16, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT END OF CORKSCREW WON'T CONNECT INTO POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894740 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT HAD A METAL CHIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844901 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT THE CORKSCREW WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788771 ↗
• MalfunctionMar 30, 2026Break

  ITEMS BROKE AT ATTACHMENT POINT TO DRILL. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO . WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716916 ↗
• MalfunctionMar 30, 2026Break

  ITEMS BROKE AT ATTACHMENT POINT TO DRILL DURING PROCEDURE. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716529 ↗
• MalfunctionMar 11, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCT HAD AN UNKNOWN ALLEGATION. IT DID NOT HAPPENED IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE ADAPTERS HEAD WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569418 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A CORKSCREW HANDLE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508167 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT THE MODULAR HEAD BALL REMOVER HAD A BROKEN CORKSCREW. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378011 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE BELOW CORKSCREWS WERE NOT SEATING IN THE DRILLS APPROPRIATELY ANYMORE. THE SURGEON REQUESTED NEW ONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321625 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE BELOW CORKSCREWS WERE NOT SEATING IN THE DRILLS APPROPRIATELY ANYMORE. THE SURGEON REQUESTED NEW ONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321601 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SHAFT ENDS THAT CONNECT TO THE DRILL ON BOTH THE PINN GB STRAIGHT GRATER HNDL AND THE MODULAR HEAD BALL REMOVER INSTRUMENTS BROKE. THERE WAS NO PATIENT IMPACT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272203 ↗
• MalfunctionFeb 3, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CORKSCREW WAS BROKEN AND WOULD NOT CONNECT TO THE HUDSON ADAPTER OR TO THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247717 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CORKSCREW WOULD NOT ATTACH TO THE QUICK CONNECT ATTACHMENT FOR POWER. IT APPEARED TO BE WORN DOWN AT THE ATTACHMENT POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086284 ↗
• MalfunctionJan 13, 2026Structural Problem

  IT WAS REPORTED THAT THE CONNECTION ON THE MODULAR HEAD BALL REMOVER FAILED TO LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052995 ↗
• MalfunctionJan 13, 2026Structural Problem

  IT WAS REPORTED THAT THE CONNECTION ON THE MODULAR HEAD BALL REMOVER FAILED TO LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052987 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT THE END OF CORKSCREW BROKE. ALL PIECES WERE LOCATED AND REMOVED FROM THE FIELD, AND DISPOSED OF IN SHARPS BIN. THERE WAS NO DELAY IN CASE OR HARM DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878463 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENT WAS NOT STAY IN DRILL CHUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741924 ↗
• MalfunctionDec 5, 2025Material Deformation; No Apparent Adverse Event; Material Deformation; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE MODULAR HEAD BALL REMOVER DEVICE WAS DEFORMED/BENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726177 ↗