TRI-LOCK 2012-03-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295082088), received between Jan 31, 2018 and Aug 1, 2023 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT UPON INSERTING BROACH INTO BROACH HANDLE/ADAPTER, IT WOULD NOT INSERT PROPERLY. THE BROACH WAS NOT ABLE TO BE USED. NOTHING LEFT IN PATIENT AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436246 ↗
• MalfunctionJul 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE IN QUESTION WAS USED IN THE SURGERY. IN THE SURGERY, THE SAID PRODUCT HAD A TIGHT CONNECTION TO THE OFFSET HANDLE, MAKING IT DIFFICULT TO ATTACH AND DETACH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17369830 ↗
• 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 16952909 ↗
• MalfunctionOct 31, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SURGEON THINKS THE POST ON THE TOP OF THE BROACH IS BENT BECAUSE IT WILL NOT SMOOTHLY ENGAGE WITH THE BROACH HANDLE. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699667 ↗
• MalfunctionSep 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  SIZE 3 BROACH IS MISMATCHED FROM THE SIZE 3 STEM. THE STEM SAT UP DURING ATTEMPTED IMPLANTATION AND A NEW ONE WAS NEEDED. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392096 ↗
• MalfunctionFeb 8, 2022Break; Device-Device Incompatibility; Scratched Material; Break; Device-Device Incompatibility; Scratched Material

  INSTRUMENTS ARE BROKEN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482079 ↗
• MalfunctionAug 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCRUB NURSE OBSERVED THAT THE BROACH DID NOT EASILY GO INTO OR COME OFF FROM THE KINCISE STRAIGHT BROACH ATTACHMENT. THE BROACH ATTACHMENT WORKED WITH OTHER BROACHES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307311 ↗
• 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 10235568 ↗
• MalfunctionMay 28, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SURGEON BROACHED UP TO A 3 BROACH AND IMPLANTED A SIZE 3 THRILOCK STD. IT SAT PROUD AND AFTER REBROACHING IT STILL SAT PROUD. HE THEN REMOVED THE STEM AND BROACHED UP TO A 4 THEN IMPLANTED A NEW SIZE 3. THIS DELAYED THE CASE ABOUT 5-10 MINUTES BUT WAS NOT DETRIMENTAL TO THE OUTCOME. I WILL WASH AND RETURN THE IMPLANT IN QUESTION. DOE: (B)(6) 2020. AFFECTED SITE: UNKNOWN.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10097527 ↗
• MalfunctionNov 8, 2019Inadequacy of Device Shape and/or Size; Device-Device Incompatibility; Inadequacy of Device Shape and/or Size; Device-Device Incompatibility

  DR COMPLAINED THAT THE BROACH WAS SITTING SIGNIFICANTLY LOWER THAN THE FINAL IMPLANT. HE USED ANOTHER STEM AND IT DID THE SAME THING SO HE REQUESTED A 3RD IMPLANT.

  Patient problems: Not Applicable

  MAUDE report 9296332 ↗
• MalfunctionJan 31, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON SAW THE BROACH TO IMPLANT MISMATCH AS TOO DRASTIC AND THOUGHT IT RISKED FRACTURING THE FEMUR. HE REQUESTED A NEW IMPLANT AND TO HAVE THE INITIAL IMPLANT AND CORRESPONDING BROACH TO BE SENT IN FOR TESTING. ACTION TAKEN-NEW SIZE 3 STD IMPLANT OPENED. IT AFFECTED THE LENGTH OF THE CASE BY ADDING 5-7 MINUTES BUT DID NOT AFFECT THE PATIENT OUTCOME.

  Patient problems: No Code Available

  MAUDE report 8293771 ↗
• MalfunctionJan 23, 2019Break; Break

  THE BROACH HANDLE BROKE OFF. ALL PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270162 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SIZE 3 TRILOCK STEMS WERE NOT SITTING AT AN ACCEPTABLE DEPTH RELATIVE TO THE SIZE 3 TRILOCK BROACH. AFTER REBROACHING THE CANAL THE STEM STILL SAT AT A CM ABOVE THE DESIRED DEPTH.

  Patient problems: No Code Available

  MAUDE report 8186962 ↗
• MalfunctionJul 10, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7673081 ↗
• MalfunctionJul 10, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7673075 ↗
• MalfunctionJul 10, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7673067 ↗
• MalfunctionJul 10, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7673054 ↗
• MalfunctionJul 10, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME. THE PRODUCT MANAGERS HAVE SAID WE NEED TO REPLACE THE BROACHES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7673044 ↗
• MalfunctionApr 27, 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 7469054 ↗
• MalfunctionApr 27, 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 7468975 ↗
• MalfunctionApr 27, 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 7468617 ↗
• MalfunctionApr 27, 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 FROM EACH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7468461 ↗
• 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 EACH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7464847 ↗
• 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 7464615 ↗
• 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 7464355 ↗