LCP 241.401Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982166951), received between Dec 14, 2017 and Nov 11, 2022 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K011335); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY (B)(6) 2021 STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE (1)LCP ONE-THIRD TUB PL COLLAR 10 H/117 THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15779069 ↗
• InjuryAug 25, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON REMOVED A BROKEN 1/3 TUBULAR PLATE AND 7 SCREWS FROM A FIBULA. THE HARDWARE WAS SUCCESSFULLY REMOVED. THE PATIENT DID EXPERIENCED A POST-OP DEVICE MALFUNCTION OF BROKEN PLATE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUB PL COLLAR 10 H/117. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15293168 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL OF ANKLE HARDWARE DUE TO FUNGAL INFECTION AND BONE LOSS. THE ORIGINAL FRACTURE WAS AN OPEN WOUND AND OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS PERFORMED ON (B)(6) 2021. THE DISTAL TIBIA WAS RESPECTED ALONG WITH THE PORTION OF TALUS. MAXFRAME WAS APPLIED ON (B)(6) 2022, WITH THE PLAN TO DO A TRANSPORT ONCE THE INFECTION RESOLVES. THERE WAS NO POST-OPERATIVE DEVICE MALFUNCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A TUBULAR PLATE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14162315 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THERE WAS A REMOVAL OF ONE (1) LCP 1/3 TUBULAR PLATE COLLAR 10 HOLE AND EIGHT (8) UNKNOWN 3.5 CORTICAL SCREWS. THE PATIENT HAD AN INFECTION UNRELATED TO THE DEVICES. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES/117MM THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 13891535 ↗
• MalfunctionOct 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SURGEON ATTEMPTED TO PUT A GUIDE BLOCK AND SCREW THROUGH THE DRILL HOLES. THE ISSUE OCCURRED WHILE THE ATTACHMENT SCREW GOING TO THE PATIENT'S BODY VIA THE GUIDE BLOCK. WE ARE DOING A DISTAL FIBULA PLATE FOR A PATIENT AND DRILLED FOR A LOCKING SCREW THEN USE THE POWER SHAFT. THE LOCKING SCREW WOULD NOT STICK TO THE TIP OF THE SCREWDRIVER SHAFT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE HAND SCREWDRIVER AND A SURGICAL DELAY OF THIRTY(30) SECONDS. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: DISTAL RADIUS: (PART#UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUB PL COLLAR 10 H/117. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665207 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AUGUST 22, 2021 DURING AN UNKNOWN PROCEDURE, THE HARDWARE IN QUESTION WAS REMOVED DUE TO INFECTION. IT IS UNKNOWN WHEN THE HARDWARE WAS ORIGINALLY IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES/117MM. THIS IS REPORT 1 OF 11 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12488504 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL IN TIBIA DUE TO INFECTION OR NONUNION, AND AN UNKNOWN EXTERNAL FIXATION WAS PLACED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) ON (B)(6) 2020. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES/117MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 10684983 ↗
• InjuryMay 14, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, PATIENT UNDERWENT REMOVAL OF LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE BECAUSE IT WAS DISCOVERED THAT THE PLATE HAD FAILED AND SNAPPED IN HALF. ON 2018 TWO (2) LCP PLATES WAS INSERTED AFTER AN INJURY WAS SUSTAINED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: UNKNOWN), LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE (PART #: 241.401, LOT #: UNKNOWN, QUANTITY #: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8609614 ↗
• InjuryMay 3, 2019Break; Break

  CONCOMITANT MEDICAL PRODUCTS : STARDRIVE CORTEX SCREW SELF-TAPPING 16MM (PART# 02.200.016, LOT# H653998, QUANTITY 1), LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 14MM (PART# 212.103, LOT# UNKNOWN, QUANTITY 1), LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 16MM (PART# 212.104, LOT# UNKNOWN, QUANTITY 1), STARDRIVE CORTEX SCREW SELF-TAPPING 14MM (PART# 02.200.014, LOT# H677890, QUANTITY 1, STARDRIVE CORTEX SCREW SELF-TAPPING 14MM (PART# 02.200.014, LOT# H382054, QUANTITY 1), STARDRIVE CORTEX SCREW SELF-TAPPING 14MM (PART# 02.200.014, LOT# H363128, QUANTITY 1).

  Patient problems: No Code Available; Pain

  MAUDE report 8578123 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 DUE TO LONG SCREWS, SHORT FIBULA, AND UNREDUCED SYNDESMOSIS. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A 10-HOLE TUBULAR LOCKING COMPRESSION PLATE (LCP) AND SEVEN (7) 3.5 SCREWS WITH VARYING LENGTHS ON AN UNKNOWN DATE. REVISION WAS DONE AND WAS IMPLANTED WITH A NEW SET OF HARDWARE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR A 10-HOLE TUBULAR LOCKING COMPRESSION PLATE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7735035 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT WAS PRESENTED WITH A LEFT TIBIA AND FIBULA FRACTURE. THE SURGEON PLACED ONE LCP ONE-THIRD TUBULAR PLATE IN THE PATIENT WITH SEVEN (7) CORTICAL SCREWS AND ONE PARTIALLY THREADED CANCELLOUS SCREW. SHE ALSO INSERTED AN 8MM TI CANNULATED TIBIAL NAIL WITH TWO (2) LOCKING SCREWS (ONE DISTAL AND ONE PROXIMAL). IN (B)(6) 2018, THE PATIENT PRESENTED A NON-UNION OF THE LEFT TIBIA AND FIBULA. ON (B)(6) 2018 THE SURGEON REMOVED THE LCP ONE-THIRD TUBULAR PLATE AND THE PROXIMAL LOCKING SCREW TO PROMOTE HEALING. THE SURGERY WAS COMPLETED WITH NO DELAYS AND THERE WAS NOT HARM TO THE PATIENT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7425030 ↗
• InjuryDec 14, 2017Break; Break

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL PROCEDURE IN (B)(6) 2017 FOR TREATMENT OF AN OPEN REDUCTION INTERNAL FIXATION FOR A RIGHT FIBULA FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) LOCKING COMPRESSION ONE-THIRD TUBULAR PLATE WITH COLLAR, AND TEN (10) 3.5MM LOCKING AND NON-LOCKING COMBINATION OF CORTEX SCREWS. ON AN UNKNOWN DATE POST-OPERATIVELY, PATIENT PRESENTED WITH A BROKEN PLATE WITH A NON-UNION. THE PLATE WAS REPORTED AS BROKEN AT THE 4TH SCREW HOLE POSITION. THE PLATE BREAKAGE WAS IN THE MIDDLE OF THE PLATE. ALL TEN SCREWS WERE REPORTED IN GOOD CONDITION. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A DISTAL FIBULA PLATE AND SCREWS. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. IMPLANTS WILL BE RETURNED FOR EVALUATION. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREWS (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 5), UNKNOWN CORTEX SCREWS (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 6). THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7118260 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011335. One submission often covers many models, so check the product and lot details in each record.

• Z-2816-2020 · Jul 21, 2020 · Terminated
  DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, ol
• Z-1557-2013 · Feb 22, 2013 · Terminated
  Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011