Lapiplasty® 4.0mm Fully Threaded Screw SK37Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00853114006297), received between Dec 6, 2023 and Sep 11, 2026 — classified as 5 injuries, 1 malfunction.

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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Break

  Patient problems: Pain

  MAUDE report 50740829 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, A FULLY THREADED SCREW WAS REMOVED FROM THE PATIENT'S RIGHT FOOT ON (B)(6) 2026 AS THE SURGEON WAS CONCERNED THAT THE 1ST METATARSAL WAS PUSHED TOO FAR LATERALLY CAUSING HALLUX TO MOVE INTO A VARUS POSITION. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Malunion of Bone

  MAUDE report 24482103 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A FRACTURED MEDIAL CUNEIFORM AND SMASHED PROXIMAL MEDIAL METATARSAL BASE. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL TMC DEVICES EXPLANTED IN THE SAME REVISION SURGERY WERE REPORTED IN 3011623994-2025-00023.

  Patient problems: Bone Fracture(s)

  MAUDE report 21610511 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2024 AFTER THE PATIENT KICKED SOMETHING GETTING OUT OF THE SHOWER, CAUSING PAIN, WITH THE 1ST TMT OPENING AND CAUSING PLANTER GAPPING. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 20701117 ↗
• InjuryApr 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO INFECTION AND A WOUND AT THE INCISION SITE. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19149821 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT THE HEAD OF A FULLY THREADED SCREW BROKE OFF AND THE SCREW WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6). THERE WAS NO REPORT OF DELAY, NOR IMPACT OR INJURY TO THE PATIENT AS A RESULT OF THE EVENT. ALTHOUGH THIS MALFUNCTION HAS NOT RESULTED IN A REVISION SURGERY TO DATE IN THIS EVENT, THERE HAVE BEEN SIMILAR EVENTS WHERE THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY. THEREFORE, A MDR WILL BE FILED TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18280224 ↗