SPECIALIST 96-6120Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295246893), received between Aug 24, 2016 and Mar 16, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Sep 8, 2015Class IITerminated

   DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.

   Z-0111-2016 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Break; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENT HAD METAL CHIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605833 ↗
• MalfunctionAug 4, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, DURING THE IMPLANTATION OF THE SIGMA CR WITH THE HIGH PERFORMANCE SURGICAL INSTRUMENT SET, A CRACKING SOUND WAS HEARD DURING ROUTINE USE OF THE ROD; AFTER REMOVING THE ROD FROM THE CANAL, IT WAS DISCOVERED THAT THE DISTAL PART REMAINED IN THE CANAL. ATTEMPTS TO EXTRACT A FRAGMENT OF THE TIP OF THE ROD WERE MADE WITHOUT SUCCESS. PATIENT WAS DISCHARGED. PLAN FOR PATIENT MANAGEMENT IS OBSERVATION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698712 ↗
• MalfunctionAug 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IM ROD DOES NOT CAPTURE THE DISTAL FEMORAL JIG. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19937327 ↗
• MalfunctionMay 21, 2024Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn

  IT WAS REPORTED THAT THE ITEM IS WORN AWAY AT THE END AND GETTING JAMMED IN OUTRIGGER. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358968 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT THE BEARINGS BROKE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891562 ↗
• MalfunctionDec 6, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTACHMENT END WHERE THE T-HANDLE ATTACHES IS BROKEN IT DOESN¿T ALLOW THE T-HANDLE TO BE ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 18275439 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315781 ↗
• MalfunctionJun 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  BLIND UNIT RECEIVED IN LOCAL STOCK MARKED WITH RED TAPE WITHOUT PC IDENTIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080995 ↗
• MalfunctionMar 21, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THE HANDLE IS CRACKED/SPLIT, THE OSTEOTOME IS BLUNT, AND THE END OF THE ROD WHERE THE T-HANDLE ATTACHES IS WORN AND THE HANDLE WILL NOT STAY ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581681 ↗
• MalfunctionMar 6, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DEVICE IS WORN OUT AT THE BALL JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488019 ↗
• MalfunctionMar 6, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DEVICE IS WORN AT THE BALL JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487994 ↗
• MalfunctionFeb 9, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE STOPPER AT END OF IM ROD IS WORN OUT, SO THAT IT DOES NOT CATCH WHEN PULLING JIG OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335784 ↗
• MalfunctionJan 12, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING PROCEDURE INTRAMEDULLARY GUIDE ROD WAS USED FOR TIBIAL PREPARATION OF TIBIAL CUT. INTRAMEDULLARY GUIDE ROD WAS INSERTED AND TIBIAL CUTTING JIG WAS SET IN PLACE. WHITE TIBIAL CUTTING JIG AND INTRAMEDULLARY GUIDE ROD WERE BEING EXTRACTED THE REP WAS ASSISTING THE SURGICAL TECH IN PREPARATION OF NEXT INSTRUMENTS FOR THE PROCEDURE. WHEN THE INTRAMEDULLARY GUIDE ROD WAS FULLY EXTRACTED THE DOCTOR HAD NOTICED THAT THE TIP OF THE GUIDE ROD HAD BROKEN OFF. X-RAY WAS USED TO CONFIRM THAT THE TIP OF THE GUIDE ROD WAS STILL IN THE TIBIAL CANAL. THE BROKEN PIECE OF THE GUIDE ROD WAS NOT ABLE TO BE REMOVED AND WAS LEFT ON THE PATIENT. SURGERY WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS A FIVE MINUTE SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16145421 ↗
• MalfunctionSep 13, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE IM ROD IS NO LONGER ATTACHING TO THE HANDLE SO CAN NO LONGER BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409745 ↗
• MalfunctionJun 21, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT ROD STOPS ARE WORN DOWN AND NO LONGER PREVENT REMOVAL FROM DISTAL FEMORAL JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754138 ↗
• MalfunctionJun 16, 2022Naturally Worn; Naturally Worn

  INSTRUMENT IS WORN AND NO LONGER CATCHING AT THE END IT JUST SLIDES OFF THE END OF THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14722229 ↗
• MalfunctionMar 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  INSTRUMENTS ARE JAMMED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802360 ↗
• MalfunctionMar 11, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THE ROD IS BROKEN AND WILL NO LONGER CATCH THE DISTAL FEMORAL JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13739133 ↗
• MalfunctionDec 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  WE HAVE BEEN NOTIFIED TODAY BY (B)(6) AT (B)(6) THAT AN ITEM IS DEFECTIVE AND NEEDS REPLACING. THE ITEM IS 966120 ( IM ROD 400MM). THE REPORTED ISSUE IS ¿ FEMORAL CUTTING BLOCK SLIPS OF THE FEMORAL ROD WHEN IT IS EXTRACTED FROM THE KNEE¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053491 ↗
• MalfunctionJul 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IM ROD IS GETTING STUCK IN THE DISTAL FEMORAL JIG AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173016 ↗
• MalfunctionJul 9, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE END OF THE IM ROD WAS WORN FROM YEARS OF USE AND NEEDS TO BE REPLACED. NO ISSUES WERE CAUSED IN THE CASE. NO OTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145536 ↗
• MalfunctionMay 3, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE SURGEON INSERTED THE I M FEM ROD INTO THE FEMUR AND PINNED THE DISTAL CUTTING BLOCK. WHEN HE LIFTED THE T HANDLE TO REMOVE THE ROD HE FELT A "POP." ROD WAS REMOVED BUT THE TIP HAD BROKEN OFF AND WAS LEFT IN THE FEMUR. THEY DISCUSSED AS TO HOW TO REMOVE IT. SPOKE WITH OTHER SURGEON AND PATIENT¿S FAMILY. SURGEON FELT IT WOULD DO MORE DAMAGE TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766710 ↗
• MalfunctionDec 4, 2019Break; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Break; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEMORAL ROD WOULD NOT PULL OUT FROM THE DISTAL CUTTING BLOCK DUE TO WEAR OF THE INSTRUMENT. IT FINALLY BROKEN FREE AND WAS ABLE TO DISLODGE. THIS DID NOT INCREASE THE TIME OF SURGERY OR CAUSE HARM TO PATIENT. ONE OTHER ROD HAD SAME ISSUE SO ARE BEING REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412969 ↗
• MalfunctionDec 4, 2019Break; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Break; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEMORAL ROD WOULD NOT PULL OUT FROM THE DISTAL CUTTING BLOCK DUE TO WEAR OF THE INSTRUMENT. IT FINALLY BROKEN FREE AND WAS ABLE TO DISLODGE. THIS DID NOT INCREASE THE TIME OF SURGERY OR CAUSE HARM TO PATIENT. ONE OTHER ROD HAD SAME ISSUE SO ARE BEING REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412966 ↗
• MalfunctionDec 4, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  LOCATING DEVICE GETTING STUCK ON ROD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412085 ↗