Lapiplasty Select SK34Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00853114006273), received between Nov 19, 2022 and Sep 29, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50935588 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AFTER AN INITIAL BUNION SURGERY, THE MEDIAL PLATE WAS REMOVED DUE TO MILD IRRITATION AND DISCOMFORT. 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: Discomfort; Pain

  MAUDE report 20701129 ↗
• 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, THE DORSAL PLATE WAS REMOVED ON (B)(6) 2024 DUE TO MILD IRRITATION AND DISCOMFORT FROM THE HARDWARE. 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: Discomfort; Pain

  MAUDE report 20701128 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PAINFUL HARDWARE AND A TENDER AND SWOLLEN FUSION 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: Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 20660106 ↗
• InjuryOct 29, 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, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PAINFUL HARDWARE. 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 20563368 ↗
• InjuryOct 16, 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, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO A PAINFUL NAVICULAR CUNEIFORM JOINT FROM PLATE RUBBING. 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 20468107 ↗
• InjuryMay 7, 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO THE PATIENT FEELING PLATE PROMINENCE UNDER THE SKIN. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264215 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT AN OLIVE WIRE BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18008559 ↗
• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF A OLIVE WIRE DRILL BIT BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17693379 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF A THREADED OLIVE WIRE BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17595001 ↗
• MalfunctionAug 18, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF AN OLIVE WIRE DRILL BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17571886 ↗
• InjuryAug 10, 2023Adverse 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) 2023, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO PAIN AND ELEVATION OF THE 1ST METATARSAL. 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 17500098 ↗
• InjuryJul 14, 2023Adverse 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) 2022, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO NONUNION. THE SITE WAS REVISED WITH NON-TMC HARDWARE. UPON REMOVAL, 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17323983 ↗
• MalfunctionJun 11, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF AN OLIVE WIRE DRILL BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17102638 ↗
• MalfunctionDec 3, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF AN OLIVE WIRE BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2022. THE CASE WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL PATIENT OUTCOMES.

  Patient problems: Foreign Body In Patient

  MAUDE report 15911962 ↗
• MalfunctionNov 19, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF A PLATE TACK BROKE OFF AND WAS RETAINED IN THE PATIENTS BONE DURING A BUNION PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL PATIENT OUTCOMES.

  Patient problems: Foreign Body In Patient

  MAUDE report 15830664 ↗