NA 2178-65-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295096672), received between Jun 29, 2017 and Jan 11, 2024 — classified as 61 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2024Crack; Crack

  THERE WAS A CRACK ON THE MBT REV TIBIAL TRIAL. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01940616 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496379 ↗
• MalfunctionOct 24, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKE DURING TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658388 ↗
• MalfunctionAug 1, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT PLATE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141861 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT CLEAR MBT TRIAL PLATE BROKE IN HALF. ALL PIECES RETRIEVED. THERE IS NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596808 ↗
• MalfunctionSep 29, 2021Break; Break

  ALL VIEW PLATES HAVE SNAPPED IN HALF. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. CUSTOMER REFERENCE/PO/SERVICE: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547230 ↗
• MalfunctionAug 3, 2021Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267122 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT WHILE SIZING THE TIBIA WITH THE SIZER, THE SIZER BROKE IN HALF. IT BROKE INTO TWO PIECES. BOTH PIECES ARE BEING RETURNED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820040 ↗
• MalfunctionApr 26, 2021Break; Break

  217865130 VIEW PLATE HAS SNAPPED IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725231 ↗
• MalfunctionJan 2, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE SZ 5, 3 AND 2.5 VIEW PLATES WERE CRACKED, CHIPPED. DAMAGED FOUND WHEN THEY RETURNED TO THE OFFICE FOR INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9540618 ↗
• MalfunctionOct 2, 2019Break; Break

  IT WAS REPORTED THAT THE SIZE 3 MBT REVISION TIBIA PLATE WAS BROKEN INTO 2 PIECES. BOTH PIECES WERE REMOVED FROM THE FIELD AND VERIFIED TO BE ALL OF THE PIECES. THESE WERE REMOVED FROM THE FIELD AND DID NOT AFFECT THE PATIENT. SURGERY TIME WAS NOT EXTENDED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9147275 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE REAMERS, T-HANDLE, AND ADAPTORS CONNECTIONS ARE WORN. THE WRENCH WAS BENT. THE VIEW PLATE WAS CRACKED INTO TWO PIECES AND ALL INSTRUMENTS NEEDS REPLACEMENT. THESE ARE ALL OUT OF OFFICE SETS REPLACED TO CHARLOTTE OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075886 ↗
• MalfunctionJul 24, 2019Break; Break

  BOTH TIBIAL VIEW PLATES HAVE SNAPPED IN HALF. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821735 ↗
• MalfunctionJul 12, 2019Break; Break

  T WAS REPORTED THAT WHILE RETRIEVING THE SIZING PLATE OFF OF THE TIBIA, THE PLATE WAS FOUND TO BE BROKEN IN HALF. ALL PIECES WERE RETRIEVED. WELL USING THE SPIKED HANDLE TO TAKE OUT THE PLASTIC PIECES FOR THE ARGUMENT. THE SPEAK PIECE BECAME LODGED IN THE PLASTIC. THE PLASTIC CONTAINER IN THE SMALL SHARP PORTION WAS THROWN IN THE TRASHCAN. THE HANDLE WAS BEING RETURNED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785172 ↗
• MalfunctionJul 10, 2019Break; Break

  IT WAS REPORTED THAT THE MBT REV TIBIAL VIEW PLATE S23 BROKE INTO MULTIPLE PIECES WHILE BEING IMPACTED. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775971 ↗
• MalfunctionJun 10, 2019Break; Break

  TIBIAL VIEW PLATE HAS SNAPPED IN HALF. PLEASE SEE. INFORMATION IS THAT THIS ITEM HAS ONLY BEEN USED A HANDFUL OF TIMES. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. CUSTOMER REFERENCE/PO/SERVICE (B)(4), PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF:NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684469 ↗
• MalfunctionMay 23, 2019Material Deformation; Material Deformation

  SCUFFED PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637596 ↗
• MalfunctionMay 6, 2019Break; Break

  TIBIAL VIEW PLATE ((B)(4)) HAS SNAPPED IN HALF. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583823 ↗
• MalfunctionApr 1, 2019Break; Material Discolored; Material Deformation; Break; Material Discolored; Material Deformation

  IT WAS REPORTED THAT AFTER CASE UPON INSPECTION SZ 3 AMBER VIEW PLATE WAS CHIPPED AND NEEDS TO BE REPLACED. DID NOT AFFECT TIME OF CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469533 ↗
• MalfunctionMar 22, 2019Break; Break

  SURGEON WAS USING THE VIEW PLATE TO REAM THROUGH TO MAKE SURE HE WAS CENTERED. REAMED UP AND THEN DIDN'T REMOVE IT BEFORE THE PROXIMAL REAMER AND IT CRACKED AND BROKE THE VIEW PLATE. ALSO, SPD NOTICED WHEN THEY WERE PUTTING THE SET BACK TOGETHER THAT THE OTHER PLATE WAS CRACKED. UNSURE OF WHEN THAT HAPPENED WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> REMOVED BROKEN 2 PIECES AND MOVED ON, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> YES, IF NO, EXPLAIN --> PERFECT BREAK IN TWO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, ACTIVITY LEVEL --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->HOSPITAL, DEVICE IN POSSESSION OF -->SPD, (B)(4). DEVICE PROPERTY OF -->HOSPITAL, DEVICE IN POSSESSION OF -->(B)(6). BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8444837 ↗
• MalfunctionMar 7, 2019Break; Break

  IT WAS REPORTED THAT THE MBT VIEW PLATE WAS BROKEN IN HALF. THIS DID NOT OCCUR DURING SURGERY. THE BROKEN VIEW PLATE WAS FROM OFFICE SET 02.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400928 ↗
• MalfunctionFeb 22, 2019Crack; Crack

  IT WAS REPORTED THAT VIEW PLATES WERE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361296 ↗
• MalfunctionJan 23, 2019Crack; Crack

  IT WAS REPORTED THAT THE VIEW PLATES ARE CRACKED, BUT INTACT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8271656 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270351 ↗
• MalfunctionJan 15, 2019Crack; Crack

  IT WAS REPORTED THAT THE INSTRUMENT TRIALS WAS CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248360 ↗
• MalfunctionDec 20, 2018Crack; Crack

  IT WAS REPORTED THAT THE TRIALS ARE CRACKED. (B)(6) WILL NOT LOCK ONTO REAMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184797 ↗