NA 292.12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20886982180343), received between Apr 6, 2018 and May 29, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN (B)(6) 2015 TO (B)(6) 2023 AT SANFORD RESEARCH. SUBJECT ID 4: A 73-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FRACTURE FIXATION (OPEN REDUCTION INTERNAL FIXATION RIGHT ANKLE). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: - MALUNION, HARDWARE FAILURE REQUIRING ANKLE ARTHRODESIS WITH INTERNAL AND EXTERNAL FIXATION. IMPLANT(S) INVOLVED: 02.113.103. UNKNOWN SCREWS X 2. K-WIRE - 292.12. THIS COMPLAINT INVOLVES A TOTAL OF 12 IDENTIFIED PATIENTS. THIS PC IS CREATED TO CAPTURE SUBJECT ID 4. THIS IS RELATED TO (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 22103806 ↗
• MalfunctionMay 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SEVERAL PACKAGES OF K-WIRES WERE RECEIVED WITH BENT WIRES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078505 ↗
• MalfunctionJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  7/3/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN SURGERY TO FIX A FOOT, A K-WIRE WAS USED FOR PROVISION FIXATION AND IT BROKE OFF WHEN IT WAS REMOVED. AN UNKNOWN PLATE AND SCREWS WERE USED TOGETHER WITH THE K-WIRE. IT BROKE IN TWO PIECES, OTHER HALF WAS LEFT IN PATIENT¿S FOOT AND THE OTHER HALF WAS DISCARDED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - PLATES: FOOT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) . THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8746218 ↗
• MalfunctionOct 4, 2018Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5079302, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933588 ↗
• MalfunctionApr 6, 2018Break; Break

  IT WAS REPORTED ON MAUDE REPORT MW5075288 THAT A K WIRE BROKE INTRAOPERATIVELY WHILE BEING INSERTED ON (B)(6) 2018. THE SURGEON RETRIEVED THE FRAGMENTS. NO INFORMATION IS KNOWN ON SURGICAL DELAY OR PATIENT STATUS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7403783 ↗