NA 2178-63-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295096085), received between Oct 20, 2017 and Sep 4, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE BROACH IMPACTOR NOT SITTING ALL THE WAY DOWN ON THE 37 MM BROACH WHICH CAUSED ROUGHLY A 2 MINUTE DELAY. THE HANDLE WORKED WITHOUT ISSUE ON BOTH THE 29MM AND 45MM BROACHES SO ASSUMING THERE WAS A BURR OR SOME TYPE OF ISSUE WITH THE CONNECTION ON THE 37 BROACH.

  Patient problems: Insufficient Information

  MAUDE report 20133972 ↗
• MalfunctionJul 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BOTH HUDSON ADAPTORS WOULD NOT HOLD THE 16 MM REAMER. BOTH THE HUDSON¿S AND THE REAMER NEEDS TO BE REPLACED. BOTH OF THE TIBIAL BROACHES WOULD NOT HOLD A STEM TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242300 ↗
• MalfunctionApr 26, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE BROACHES ARE DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726935 ↗
• MalfunctionApr 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE OPERATING THE DOCTOR FOUND THE FOLLOWING DEFECTS: ON SLEEVE BROACH 37 THE CARD STEMS CANNOT BE PUT ON IT. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE. PART NUMBER 860284 NEEDS TO BE REPLACED IT NO LONGER TORQUED. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE. ARTICLE NUMBER 201103080 IS DEFECTIVE. THE PLASTIC IS TORN ON THE INSIDE. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691368 ↗
• MalfunctionOct 2, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE PRODUCT D961673 IS WORN AND NEEDS TO BE REPLACED, THE BLACK END THAT GOES OVER THE IMPLANT TO TIGHTEN WAS SLIPPING WHEN THE SURGEON WAS PUTTING IMPLANTS TOGETHER. PRODUCT D217863109 AND D217863111 ARE NOT HOLDING STEM TRIALS WELL DUE TO THE WEAR AT THE CONNECTION SITE. NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10623991 ↗
• MalfunctionMay 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO TIBIAL BROACHES WOULDN¿T SECURELY HOLD THE STEM TRIALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10061755 ↗
• MalfunctionDec 23, 2019Crack; Device-Device Incompatibility; Material Twisted/Bent; Crack; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE O-RING HAS BEEN DAMAGED AND STEMS WON'T STAY ATTACHED. WAS NOT BROKEN INTO MULTIPLE PIECES AND EVERYTHING WAS RECOVERED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9510967 ↗
• MalfunctionDec 16, 2019Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 37 MBT REVISION BROACH APPEARED TO BE MANUFACTURED IN A WAY THAT IT WAS NOT COMPATIBLE WITH THE MBT REVISION BROACH HANDLE. BROACHES HAD TO BE MALLETED IN AND EXTRACTED WITHOUT THE BROACH HANDLE 45 ALSO APPEARS TO BE THE SAME. THERE WAS A 20-25 MINUTES SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9476776 ↗
• MalfunctionJun 12, 2019Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE BROACH TRIAL IS MISSING THE ORANGE RING ON THE BOTTOM PORTION OF THE INSTRUMENT. THIS HAD NO IMPACT ON SURGERY AND WAS NOT USED DURING THE CASE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691415 ↗
• MalfunctionFeb 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FAILURE IS THE O RING COMPONENT IS BECOMING DISASSOCIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347614 ↗
• MalfunctionJan 30, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  THE STEM TRIAL DID NOT HOLD IN PLACE. SPRING INSIDE WAS LOOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288909 ↗
• MalfunctionJan 17, 2019Component Missing; Component Missing

  WORN INSTRUMENTS, NEED TO BE REPLACED. SOME OF THE "O RINGS" ARE MISSING FROM THE REAMERS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8258617 ↗
• MalfunctionNov 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DURING SURGERY THE TIBIAL FEMORAL SLEEVE CLAMP REPEATEDLY LOCKED OPEN IN CERTAIN POSITIONS, AND NEEDED TO BE SHAKEN IN ORDER TO GET IT TO FUNCTION AGAIN. THE 2 DEG BROACH 37 MM WOULD NOT ACCEPT ANY OF THE STEM TRIALS (75 X 12MM SPECIFICALLY). THE STEM TRIAL WOULD NOT FIT FAR ENOUGH INTO THE BROACH FOR THE TABS TO LOCK INTO THEIR ASSIGNED SLOTS. THE STEM SAT TO PROUD A COUPLE OF MM AND WOULDN'T SEAT PROPERLY, AS IF SOMETHING WAS IN THE HOLE IT WAS MEANT TO SIT IN. UPON EXAMINATION NOTHING COULD BE SEEN THAT WOULD CAUSE THIS ISSUE. ACTION TAKEN TO MANAGE THE PROBLEM DURING SURGERY: PERSISTENT ATTEMPTS TO GET THE CLAMP TO FUNCTION AS DESIGNED, SHAKING, JIGGLING, INVERTING. SURGEON MOVED TO THE NEXT SIZE BROACH (45MM). 2 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8070280 ↗
• MalfunctionOct 30, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DOCTOR AND SCRUB NURSE STRUGGLED CONNECTING BROACHES AND REAMERS TO TRIAL STEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019201 ↗
• MalfunctionOct 11, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE 4 BROACHES FOR THE TIBIAL SLEEVES DO NOT ATTACH TO THE UNIVERSAL SLEEVE TRIALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958081 ↗
• MalfunctionJun 25, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE TIBIAL BROACHES ARE MISSING THE RUBBER RING INSIDE THE BROACHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635282 ↗
• MalfunctionMay 7, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE ANT 37MM - BROACH HANDLE WOULD NOT ENGAGE OR CONNECT WITH THIS BROACH. DID NOT USE DURING THIS SURGERY. NOTHING WAS LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491154 ↗
• MalfunctionMay 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE CASE, A FEW OF THE TRIALS USED DID NOT EFFECTIVELY HOLD ONTO THE STEM TRIALS. THIS DID NOT CREATE ANY MAJOR DELAYS HOWEVER TWICE THE STEM TRIAL CAME LOOSE AND HAD TO BE RETRIEVED FROM THE PATIENT'S TIBIA. FOLLOWING THE CASE, I TESTED THESE TRIALS AND BROACHES AND WILL BE RETURNING THEM TO GET NEW ONES. THE RUBBER GASKET ARE GETTING WORN OUT. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7479142 ↗
• MalfunctionNov 8, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT STEM TRIALS WOULD NOT STAY CONNECTED TO THE BROACH AND WERE FALLING DOWN THE CANAL.

  Patient problems: No Information

  MAUDE report 7009644 ↗
• MalfunctionOct 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RUBBER O-RING AT PILOT SHAFT CONNECTION SITE HAS DETERIORATED.

  Patient problems: No Information

  MAUDE report 6965066 ↗