TRI-LOCK 2012-05-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295082200), received between Jan 31, 2019 and Sep 9, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  WHILE DOING HIP TRIAL, SURGEON NOTICED THAT THE TRIAL HEAD WOULD NOT FIT ON NECK SEGMENT. SEEMS THE METAL RING AROUND NECK SEGMENT HAS SOMEHOW EXPANDED AND IS A LITTLE TOO BIG. 5 MINUTES DELAY, TIME TO OPEN ANOTHER INSTRUMENT TRAY. NO HARM TO PATIENT. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO.

  Patient problems: Not Applicable

  MAUDE report 8975454 ↗
• MalfunctionMar 14, 2019Material Discolored; Scratched Material; Material Discolored; Scratched Material

  THERE IS SOME SLIGHT DISCOLORATION AROUND THE ETCHING; HOWEVER, THE SIZE IS STILL READABLE. VISUAL ANALYSIS FOUND A SIGNIFICANT AMOUNT OF SCRATCHING AROUND THE NECK OF THE TRIAL.

  Patient problems: Not Applicable

  MAUDE report 8419948 ↗
• MalfunctionJan 31, 2019Material Twisted/Bent; Material Twisted/Bent

  THE RING THAT HELPS SECURE THE CONNECTION BETWEEN TWO MATING COMPONENTS WAS DEFORMED AND BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292869 ↗