TRI-LOCK 2012-03-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295082071), received between Mar 15, 2018 and Jan 21, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ONE OF THE CUTTERS CONTAINED ORGANIC MATERIAL. THE DEVICE IS PART OF LOAN SET AND IT WAS DECONTAMINATED IN MIELE MACHINE IN (B)(6). NO IMPACT ON THE PATIENT. NO DELAY IN SURGERY. IT DID NOT CHANGE THE SURGICAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314100 ↗
• 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 10235571 ↗
• MalfunctionApr 26, 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 7464260 ↗
• MalfunctionApr 17, 2018Device Operates Differently Than Expected

  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 7437796 ↗
• MalfunctionApr 17, 2018Device Operates Differently Than Expected

  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 7437789 ↗
• MalfunctionApr 17, 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 7437779 ↗
• MalfunctionApr 17, 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 7437763 ↗
• MalfunctionApr 17, 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 7437756 ↗
• MalfunctionApr 17, 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 7437743 ↗
• MalfunctionMar 20, 2018Scratched Material; Scratched Material

  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. SCRATCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353028 ↗
• MalfunctionMar 20, 2018Scratched Material; Scratched Material

  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. SCRATCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352989 ↗
• MalfunctionMar 15, 2018Scratched Material; Scratched Material

  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 7340964 ↗
• MalfunctionMar 15, 2018Scratched Material; Scratched Material

  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 7340956 ↗