TRI-LOCK 2012-03-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295082064), received between Mar 15, 2018 and Apr 8, 2022 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TRI LOCK BROACH AND CALCAR PLANAR MEDIUM GOT STUCK TOGETHER AND WHEN TRYING TO DISLODGE BENT BROACH ATTACHMENT. ALL PIECES RETRIEVED. THERE IS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053366 ↗
• 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 10235557 ↗
• MalfunctionApr 23, 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 7450987 ↗
• MalfunctionApr 23, 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 7450950 ↗
• MalfunctionApr 23, 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 7450890 ↗
• 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 7437718 ↗
• 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 7437692 ↗
• 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 7437662 ↗
• 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 7437648 ↗
• 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 7340947 ↗
• 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 7340939 ↗
• 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 7340935 ↗
• 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 7340918 ↗