TRI-LOCK 2012-03-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295082118), received between Mar 20, 2018 and Feb 14, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO ATTACH THE BROACH OF SIZE 6, THE BROACH COULD NOT BE ATTACHED TO THE HANDLE. THE SURGEON HAD NO CHOICE BUT TO USE A BROACH OF SIZE 7 BUT FAILED TO ACHIEVE PROPER REDUCTION. THEREFORE, THE SURGEON USED A BROACH WITH A SIZE OF 5 TO REAM THE CALCAR DEEPLY AND IMPLANTED A REAL IMPLANT OF SIZE 6, WHICH APPEARED TO BE SUCCESSFUL IN REDUCTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 20 MINUTES DELAY. THE BROACH IN QUESTION COULD NOT BE ATTACHED TO A SUMMIT UNIVERSAL BROACH HANDLE EITHER WHICH WAS PREPARED AS A SPARE INSTRUMENT. THE SURGEON COMMENTED THAT THE HANDLE JOINT OF THE BROACH OF SIZE 6 WAS DEFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13524159 ↗
• MalfunctionOct 16, 2020Break; Break

  IT WAS REPORTED THAT THE POST ON SIZE 6 TRILOCK BROACH WAS BROKEN OFF DURING BROACHING PROCESS. BROACH HANDLE WOULD NO LONGER ATTACH TO BROACH FOR REMOVAL OF BROACH FROM BONE. A SURGICAL DELAY OF NINETY MINUTES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10691002 ↗
• 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 10235564 ↗
• MalfunctionJul 22, 2019Difficult to Remove; Connection Problem; Material Deformation; Scratched Material; Physical Resistance/Sticking; Difficult to Remove; Connection Problem; Material Deformation; Scratched Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BROACH NECK BECAME STUCK ON THE BROACH BECAUSE OF A BURR EDGE ON THE NECK. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812795 ↗
• MalfunctionApr 25, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM THOMAS JEFFERSON UNIVE HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457722 ↗
• MalfunctionApr 25, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM THOMAS JEFFERSON UNIVE HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457698 ↗
• MalfunctionApr 25, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM THOMAS JEFFERSON UNIVE HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457681 ↗
• MalfunctionApr 24, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454678 ↗
• MalfunctionApr 24, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454579 ↗
• MalfunctionApr 24, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454541 ↗
• MalfunctionApr 24, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454198 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DUE TO THE ONGOING COMPLAINTS OF THE SURGEON REGARDING BROACH TO IMPLANT MISMATCH. ALL SIZE 0-7 BROACHES WILL BE REMOVED FROM THE TRILOCK SETS FOR FURTHER TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353302 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DUE TO THE ONGOING COMPLAINTS OF THE SURGEON REGARDING BROACH TO IMPLANT MISMATCH. ALL SIZE 0-7 BROACHES WILL BE REMOVED FROM THE TRILOCK SETS FOR FURTHER TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353281 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DUE TO THE ONGOING COMPLAINTS OF THE SURGEON REGARDING BROACH TO IMPLANT MISMATCH. ALL SIZE 0-7 BROACHES WILL BE REMOVED FROM THE TRILOCK SETS FOR FURTHER TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353254 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DUE TO THE ONGOING COMPLAINTS OF THE SURGEON REGARDING BROACH TO IMPLANT MISMATCH. ALL SIZE 0-7 BROACHES WILL BE REMOVED FROM THE TRILOCK SETS FOR FURTHER TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353235 ↗