TRI-LOCK 2012-03-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295082040), received between May 14, 2019 and Feb 7, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BROACH WILL NOT ASSEMBLE TO HANDLE AS INTENDED. 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 UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18658531 ↗
• MalfunctionFeb 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BROACH WILL NOT ASSEMBLE TO HANDLE AS INTENDED. 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: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18658413 ↗
• MalfunctionFeb 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BROACH WILL NOT ASSEMBLE TO HANDLE AS INTENDED. 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 UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18658389 ↗
• MalfunctionFeb 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BROACH WILL NOT ASSEMBLE TO HANDLE AS INTENDED. 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 --> UNKNOWN, (B)(4) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18658379 ↗
• MalfunctionNov 21, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE BROACH WAS WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15836782 ↗
• MalfunctionJun 22, 2022Naturally Worn; Naturally Worn

  STARTER RASP IS DULL ON THE MEDIAL SIDE. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775575 ↗
• MalfunctionDec 20, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THERE IS A BURR LOCATED ON THE BROACH. BROACH WILL NOT ENGAGE WITH BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043568 ↗
• MalfunctionSep 23, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE STARTER BROACH WAS WORN AND NO LONGER SHARP. PLEASE SEND REPLACEMENT TO TRIDENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518488 ↗
• MalfunctionJun 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE STARTER BROACH DULLED DURING NORMAL USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959791 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED AS "TRILOCK STARTER BROACH NOT RELEASING FROM BROACH HANDLE ". NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892980 ↗
• MalfunctionMay 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  BROACH HANDLE WOULD NOT MATE WITH STARTER BROACH. HANDLE ASSEMBLED CORRECTLY WITH ALL OTHER BROACHES. ANOTHER STARTER BROACH WAS READILY AVAILABLE, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890175 ↗
• MalfunctionJul 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  SURGEON COMPLAINED THAT FEMORAL BROACHES WERE GETTING STUCK IN THE CANAL AND WAS CONCERNED THEY WERE OUT OF SPEC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10235562 ↗
• MalfunctionMay 14, 2019Break; Device-Device Incompatibility; Physical Resistance/Sticking; Break; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SIZE 8 CORAIL BROACH AND TRI LOCK STARTER BROACH WOULD GET STUCK IN THE KINCISE BROACH HANDLE BUT NOT IN THE STANDARD BROACH HANDLE. I BELIEVE THE FIT MIGHT BE TIGHTER IN THE IN THE KINCISE HANDLE IF THERE IS A SMALL DEFECT ON THE ATTACHMENT POINT OF THE BROACH. IT DIDNT AFFECT THE CASE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609714 ↗