TRI-LOCK 2012-03-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295082057), received between Feb 1, 2018 and May 18, 2023 — classified as 16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE KINCISE BROACH ADAPTER WOULDN¿T ATTACH TO THE BROACHES. LOOKS LIKE THE ¿NECK¿ OF THE BROACH HAS BEEN SCARED OR DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 16952910 ↗
• 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 10235573 ↗
• MalfunctionJun 10, 2020Break; Scratched Material; Break; Scratched Material

  AFTER SURGERY, WHEN THE TRILOCK INSTR.SET WAS BEING WASHED AND CLEANED AT STERILISATION,THEY NOTICED SOME OF THE BROACH SZ 0 METAL CUTTING POINTS WERE MISSING... WE DO NOT KNOW AS OF NOW IF THEY SHOW ON POST OP XRAY. SURGEON DID NOT NOTICE DURING SURGERY. THERE WAS NO SURGERY DELAY DUE TO THAT . I SHOULD BE ABLE TO RECUPERATE THE BROACH TOMORROW AND SEE MORE OF THE PROBLEM. IN THE MEANTIME, THE SURGEON WILL VERIFY POST OP XRAY TO SEE TRACES IF ANY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138655 ↗
• MalfunctionFeb 13, 2019Fitting Problem; Scratched Material; Fitting Problem; Scratched Material

  IT WAS REPORTED THAT THE SIZE O BROACH DID NOT MATCH UP TO THE SIZE O TRILOCK IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8335615 ↗
• 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 7450660 ↗
• MalfunctionApr 23, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) ( 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 7450599 ↗
• 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 7450580 ↗
• MalfunctionApr 20, 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 7447167 ↗
• MalfunctionApr 20, 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 7447112 ↗
• MalfunctionApr 20, 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 7447066 ↗
• MalfunctionApr 20, 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 7447021 ↗
• 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 7340911 ↗
• 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 7340909 ↗
• 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 7340901 ↗
• 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 7340889 ↗
• MalfunctionFeb 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THA, THE PLASTIC HANDLE PINNACLE INSERTER BROKE. IT WAS ALSO NOTED THE 0 BROACH STUCK IN THE HANDLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7233734 ↗