LCP 241.381Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982166913), received between Jul 30, 2018 and Mar 4, 2024 — classified as 11 injuries, 3 malfunctions.

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

1 FDA recall record name this device's identifier.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 21, 2020Terminated

   May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw

   Z-2816-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON FEBRUARY 16, 2024, THE PLATE WAS BADLY BENT DURING SHIPPING. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 8 H/93 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826922 ↗
• InjuryDec 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 SURGEON SUCCESSFULLY REMOVED THE HARDWARE FROM AN ANKLE BECAUSE OF PAIN. WAS DEVICE EXPLANTED? YES. HARDWARE/EXPLANT REMOVAL DUE TO: PAIN. DID PATIENT REQUIRE REVISION SURGERY? NO. THERE WAS NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 8 H/93. THIS IS REPORT 1 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16015441 ↗
• InjuryAug 1, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OP EVENT SURGEON NOTIFIED THAT HE IS GOING TO REMOVE HARDWARE FROM A DISTAL TIBIAL. THE REMOVAL OF THE HARDWARE WAS EXTRAORDINARILY DIFFICULT AND INVOLVED A LOT OF IMPROVISATION TO REMOVE THE BROKEN SCREWS. ALL OF THE HARDWARE WAS SUCCESSFULLY REMOVED EXCEPT SOME SMALL SHARDS OF TWO BROKEN SCREWS LEFT BEHIND AFTER THE OVER-MILL WAS RUN OVER THEM. THE REASON FOR THE REMOVAL WAS AN INFECTED NON UNION. THE ORIGINAL SURGERY WAS DONE ON (B)(6) 2021. IT APPEARS THAT THE SCREWS WERE BROKEN PRE-OPERATIVELY, BUT NOT NOTICED ON PRE-OP XRAYS. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)LCP ONE-THIRD TUBULAR PL COLLAR 8 H/93. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15141869 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 6 OF 12 FOR PC-(B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PL COLLAR 8 H/93 DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Pain

  MAUDE report 14147855 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH PLATES AND SCREWS. ON (B)(6) 2021 THE HARDWARE WAS REMOVED DUE ANKLE PAIN. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM. THIS IS REPORT 2 OF 14 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12623963 ↗
• 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 8 HOLES/93MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

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

  MAUDE report 10684977 ↗
• MalfunctionMar 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ANKLE RECONSTRUCTION PROCEDURE, AN UNKNOWN LOCKING SCREW FELL THROUGH THE LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATE HOLE WHEN THE SURGEON WAS TIGHTENING THE LOCKING SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PLATE WITH A FIVE (5) MINUTE SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9849947 ↗
• MalfunctionFeb 26, 2019Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE. A THREADED DRILL GUIDE CROSS THREADED POSSIBLY DUE TO A BURR ON THE THREAD AND CAUSED A BURR ON THE LOCKING COMPRESSION PLATE/TUBULAR PLATE WHICH POKED THE SURGEON'S FINGER. NOTHING SEEMED TO COME OFF OF THE INSTRUMENT OR PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR A LOCKING COMPRESSION PLATE/TUBULAR PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371534 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL FROM ANKLE DUE TO INFECTED NONUNION ON (B)(6) 2019. HARDWARE REMOVED WAS ONE (1) LOCKING COMPRESSION PLATE ONE -THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/ 57MM, ONE (1) LOCKING COMPRESSION PLATE ONE -THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/ 93MM, ONE (1) 2.7MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE, ONE (1) 2.4/2.7MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE T-FUSION, ONE (1) 2.7/3.5MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE ANTEROLATERAL, TWO (2) UNKNOWN 2.7 CORTEX SCREWS, FIFTEEN (15) UNKNOWN 2.7MM VA LOCKING SCREWS, TWO (2) UNKNOWN 3.5MM LOCKING SCREWS AND ELEVEN (11) UNKNOWN 3.5MM CORTEX SCREWS. THE SITE WAS I&D AND ANTIBIOTIC CEMENT WAS PLACED IN BONE VOID AND THEN A MAXFRAME WAS PLACED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS STABLE. ORIGINAL IMPLANT DATE IS REPORTED AS (B)(6) 2018. THIS REPORT IS FOR ONE (1) LOCKING COMPRESSION PLATE ONE -THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/ 93MM. THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

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

  MAUDE report 8362708 ↗
• InjuryFeb 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT RETURNED TO SURGERY AND UNDERWENT A REMOVAL OF A TUBULAR PLATE IN THE RIGHT ANKLE FRACTURE BECAUSE IT WAS BROKEN. A NEW HARDWARE WAS IMPLANTED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8361765 ↗
• InjuryFeb 8, 2019Break; Break

  IT WAS FURTHER REPORTED THAT ON (B)(6), 2018, PATIENT FELT A SNAP IN HER FOREARM. PATIENT HAD FOUND OUT TO HAVE BROKEN PLATE AT THE EMPTY SCREW AREA OF THE FRACTURE. ON (B)(6), 2019, PATIENT UNDERWENT LEFT ULNAR FRACTURE DELAYED UNION AND REMOVAL OF BROKEN HARDWARE AND REVISION OF OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain

  MAUDE report 8322631 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH A ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. ACTION TAKEN WAS IRRIGATION AND DEBRIDEMENT. HARDWARE REMOVAL OCCURRED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A LCP ONE-THIRD TUBULAR PLATE WITH COLLAR. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8180407 ↗
• InjuryDec 19, 2018Break; Break

  COMPLAINT DESCRIPTION: THE LEGAL DEPARTMENT REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT: MEDICAL NOTES FROM THE FOLLOWING PATIENT OFFICE VISITS: OFFICE VISIT (B)(6) 2013: 2 WEEKS S/P ORIF DISTAL TIBIA AND FIBULA ¿ DOING WELL ¿ PAIN CONTROLLED AND NO NUMBNESS. OFFICE VISIT (B)(6) 2014: RIGHT ANKLE ACHING. USES A CANE ¿ HAS PAIN. JOINT PAIN AND SWELLING IN EXTREMITIES RIGHT ANKLE ¿ BROKEN SCREWS DISSTI PLAT ¿ CALLUS FORMING AT BOTH TIBIA AND FIBULA ¿ NO BRIDGING OR COMPLETE UNION YET. DELAYED UNION ¿ SECONDARY TO WEIGHT BEARING. PHYSICIAN MADE PATIENT AWARE OF NON-WEIGHT BEARING AND RECOMMENDED CAST ¿ PATIENT DECLINED. ORDERED BONE STIMULATOR. OFFICE VISIT (B)(6) 2015: A NONUNION FRACTURE IS SEEN IN THE DISTAL TIBIA WITH MODERATE MEDIAL ANGULATION OF APPROXIMATELY 38 DEGREES. FRACTURES OF THE SURROUNDING FIXATION BARS ARE IDENTIFIED OF UNDETERMINED CHRONICITY. OFFICE VISIT (B)(6) 2015: PATIENT HAS RIGHT LEG PAIN AND DEFORMITY. BEEN WEARING CRUTCHES AND REPORTS A 4 MONTH HISTORY OF WORSENING PAIN. RIGHT LEG HAS A PROMINENT BOW MEDIALLY. PATIENT NOT FOLLOWING UP AS ADVISED. OFFICE VISIT (B)(6) 2015: VITAMIN D DEFICIENCY. NONUNION OF FRACTURE. CLOSED FRACTURE OF DISTAL TIBIA AND

  Patient problems: Pain

  MAUDE report 8179152 ↗
• InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN ON (B)(6) 2018. DURING THE PROCEDURE, THE FOLLOWING DEVICES WERE REMOVED; (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES, (5) 2.7 MM CORTICAL SCREWS, (3) 2.5 MM CORTICAL SCREWS, (3) 2.0 MM CANCELLOUS SCREWS. IT WAS UNKNOWN IF THERE WERE BROKEN FRAGMENTS GENERATED FROM THE DEVICE AND IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7733321 ↗

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-1557-2013 · Feb 22, 2013 · Terminated
  Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011