NA 412.106Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982210395), received between Apr 23, 2021 and Apr 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000684); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR A SUPRACONDYLAR FRACTURE OF THE FEMUR. IN THE SURGERY, AN LCP-DF PLATE WAS IMPLANTED ON THE LATERAL SIDE AND THE LCP ONE-THIRD TUBULAR PLATE WAS IMPLANTED ON THE MEDIAL SIDE. AFTER THE SURGERY, THE SCREW FOR THE LCP ONE-THIRD TUBULAR PLATE BROKE OFF. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED. THERE WERE NO PROBLEMS WITH THE OTHER SCREWS THAT CAME OUT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON HAS JUDGED THAT THE REVISION WAS UNAVOIDABLE BECAUSE OF THE MICROMOTION THAT WOULD HAVE OCCURRED. THE SURGEON COMMENTED THAT A LARGE STANDARD PLATE SHOULD HAVE BEEN USED FOR MEDIAL FIXATION AS WELL. THE PATIENT STATUS/ OUTCOME REPORTED AS STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LOCKSCR Ø3.5 SELF-TAP L20 TAN. THIS IS REPORT 3 OF 3 FOR COMPLAINT(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19080994 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, AN UNKNOWN HARDWARE REMOVAL PROCEDURE WAS PERFORMED FOR UNKNOWN REASON. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 3.5 TI LCKNG SCR SLF-TPNG SD RECESS 20 THIS REPORT IS 8 OF 11 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717885 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,