LCP 323.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10886982190659), received between Feb 6, 2017 and Sep 16, 2026 — classified as 10 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Break” (112 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 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793122 ↗
• MalfunctionSep 16, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50793057 ↗
• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT THE DRILL GUIDE FOR THE LOCKED SCREW IS BROKEN IN ITS THREADED PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448018 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH A PLATE AND A DRILL SLEEVE IN QUESTION. DURING THE SURGERY, THE SURGEON ATTEMPTED TO BEND THE PLATE IN A TWISTING DIRECTION WHILE THE DRILL SLEEVE WAS ATTACHED. TWO SURGEONS TRIED TO TWIST, AND THREAD PART OF THE DRILL SLEEVE BROKE. THERE WAS NO PART REMAINING IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY WITH THE REST OF THE DRILL SLEEVE USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215185 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT TWO LOCKING GUIDES ARE IN BAD CONDITION. ONE HAS A BADLY DAMAGED THREAD THAT ATTACHES TO THE PLATES, AND THE OTHER BROKE DURING THE PROCEDURE. THE FRAGMENT WAS REMOVED AND PLACED IN THE CLINIC'S SHARPS CONTAINER. OTHER EQUIPMENT WAS USED. THERE WERE NO SETBACKS; THE SURGICAL PROCEDURE WAS NOT PROLONGED, AND IT WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149421 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT TWO LOCKING GUIDES ARE IN BAD CONDITION. ONE HAS A BADLY DAMAGED THREAD THAT ATTACHES TO THE PLATES, AND THE OTHER BROKE DURING THE PROCEDURE. THE FRAGMENT WAS REMOVED AND PLACED IN THE CLINIC'S SHARPS CONTAINER. OTHER EQUIPMENT WAS USED. THERE WERE NO SETBACKS; THE SURGICAL PROCEDURE WAS NOT PROLONGED, AND IT WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149418 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY (B)(6) 2026, WHEN THE DEVICE WAS RETURNED, A NOTE WAS ATTACHED STATING THAT IT WAS DAMAGED. THE LOCKING PART OF THE OUTER TUBE WAS BROKEN. THE BROKEN PIECES WERE ALSO ENCLOSED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691959 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THE THREADED TIP OF THE DRILL GUIDE WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455723 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT THE LCP DRILL SLEEVE 5 F/DRILL BITS Ø4.3 BROKE AT ITS TIP DURING A PROCEDURE. THE BREAKAGE OCCURRED WHEN EXCESSIVE FORCE WAS APPLIED WHILE SLIDING THE PLATE USING THE DRILL GUIDE. THE FRAGMENTS WERE PROMPTLY REMOVED, AND THE DEVICE WAS MARKED FOR IDENTIFICATION AND REPLACEMENT. THE EVENT DID NOT RESULT IN ANY ADVERSE EFFECTS OR DISCOMFORT FOR THE SPECIALIST, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT IMPACT TO THE PATIENT OR CHANGES TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305289 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, WHEN REMOVING THE BLOCK GUIDE FROM THE PLATE, DIFFICULTY WAS ENCOUNTERED DUE TO THE GUIDE BEING STUCK. IN THIS SITUATION, THE SURGEON APPLIED GREATER FORCE TO TRY TO REMOVE IT, WHICH CAUSED THE GUIDE'S THREADS TO FRACTURE AND SUBSEQUENTLY BREAK. THE ISSUE WAS RESOLVED INTRAOPERATIVELY BY USING ANOTHER BLOCK GUIDE, WITH NO DELAY OR DISCOMFORT REPORTED FOR THE SPECIALIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293625 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A FEMORAL OSTEOSYNTHESIS FOR PERIPROSTHETIC FRACTURE AROUND TKA WITH THE DRILL GUIDE. DURING THE SURGERY, DRILLING, MEASUREMENT, AND SCREW FIXATION WERE PERFORMED AS USUAL USING A DRILL GUIDE. WHEN THE FINAL IMAGE WAS CONFIRMED, A SMALL, PREVIOUSLY UNSEEN OBJECT RESEMBLING A FRAGMENT WAS FOUND NEAR THE PLATE. THE SALES REPRESENTATIVE CHECKED THE THREADED TIP OF THE DRILL GUIDE AND DISCOVERED THAT IT WAS CHIPPED. THE FRAGMENT WAS REMOVED FROM THE BODY USING A KOCHER, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037845 ↗
• MalfunctionDec 18, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT HIGH TIBIAL OSTEOTOMY SURGERY FOR OSTEOARTHRITIS OF THE KNEE. DURING SURGERY, THE SURGEON ATTEMPTED TO ATTACH THE PRODUCT IN QUESTION TO THE SCREW HOLE IN THE SHAFT BUT WAS NOT ABLE TO DO SO. THE SURGEON USED ANOTHER DRILL GUIDE INSTEAD, AND IT COULD SMOOTHLY BE ATTACHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, THE PRODUCT IN QUESTION WAS INSPECTED AND IT WAS FOUND THAT A PART OF THE THREADED PORTION WAS MISSING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843514 ↗
• MalfunctionOct 8, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN ON AN UNKNOWN DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243925 ↗
• MalfunctionSep 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH A TOMOFIX T PLATE. THE SURGEON OPENED THE WOUND ACCORDING TO THE SURGICAL TECHNIQUE AND ATTACHED THE DRILL GUIDE IN QUESTION TO THE PLATE. WHEN THE SURGEON INSERTED THE PLATE BY HOLDING THE DRILL GUIDE, THE DRILL GUIDE GOT BENT, AND THE TIP OF THE DRILL GUIDE GOT DAMAGED. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003464 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT THE GUIDE WAS BROKEN IN THE AREA OF THE THREAD, DURING ITS USE. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY, AS ADDITIONAL DEVICES OF THE REFERENCE WERE AVAILABLE TO USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953143 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS THREAD WAS BROKEN OFF IN PLATE DURING OPERATION. NO MEASURABLE TIME DELAY. ONE FRAGMENT CREATED AND REMOVED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884704 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIGH TIBIAL OSTEOTOMY FOR KNEE OSTEOARTHRITIS WITH THE DRILL GUIDE. THE DL STAFF MEMBER WHO WAS PRESENT DURING THE SURGERY NOTICED THAT THE TIP OF THE DRILL GUIDE WAS BROKEN. SINCE IT WAS BILATERAL, TWO SETS OF INSTRUMENTS WERE DELIVERED, AND A DIFFERENT DRILL GUIDE WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828915 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED DURING USE, THE GUIDE BROKE IN THE AREA OF THE THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668641 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN THE KNOB OF THE INSTRUMENT HAS SNAPPED OFF. THERE WAS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309177 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THAT A DRILL GUIDE BREAKS WHEN ADAPTING IT TO THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185352 ↗
• MalfunctionApr 17, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? NO, THERE WERE OTHER GUIDELINES DURING THE PROCEDURE. B. WHAT WAS THE SPECIFIC DAMAGE THE DEVICE SUFFERED? WAS IT WORN, CRACKED, RUPTURED, BENT, SCRATCHED, WITH CROSSED THREADS OR ANY INTERACTION WITH THE DEVICE? DURING ITS USE IT BROKE IN THE AREA OF THE THREAD, I SUPPOSE THE THREAD WAS WORN. C. WAS THE SURGERY PERFORMED SUCCESSFULLY? (YES OR NO): YES. D. INDICATE PATIENT STATUS/OUTCOME: SUCCESSFULLY PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 21853929 ↗
• MalfunctionMar 11, 2025Break; Break

  IT IS REPORTED THAT DURING THE PROCEDURE IT OCCURS THAT THE TWO (2) THREADED GUIDES WERE BROKEN. THE FRAGMENTS WERE REMOVED AND TWO OTHER THREADED GUIDES THAT ALSO COME WITHIN THE EQUIPMENT WERE USED TO SUCCESSFUL COMPLETE THE SURGERY WITHOUT ANY DELAYS OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573958 ↗
• MalfunctionMar 11, 2025Break; Break

  IT IS REPORTED THAT DURING THE PROCEDURE IT OCCURS THAT THE TWO (2) THREADED GUIDES WERE BROKEN. THE FRAGMENTS WERE REMOVED AND TWO OTHER THREADED GUIDES THAT ALSO COME WITHIN THE EQUIPMENT WERE USED TO SUCCESSFUL COMPLETE THE SURGERY WITHOUT ANY DELAYS OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573916 ↗
• MalfunctionDec 23, 2024Break; Entrapment of Device; Device Slipped; Break; Entrapment of Device; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL NECK FRACTURE. IN THE SURGERY, THE SURGEON REMARKED THAT THE LOOSENESS WAS GREATER THAN USUAL WHEN THE SLEEVE WAS ATTACHED TO THE PLATE. DRILLING WAS PERFORMED AS IT WAS, BUT THE DRILL TIP WAS TOO LOOSE, SO AFTER REATTACHING THE DRILL TIP, DRILLING, MEASUREMENT, AND SCREW INSERTION WERE PERFORMED. WHEN THE NEXT HOLE WAS DRILLED, THE SURGEON AGAIN NOTED THAT THE LOOSENESS WAS TOO LARGE, AND WHEN THEY REMOVED THE SLEEVE TO USE A SPARE SLEEVE, THEY NOTICED THAT THE TIP OF THE SLEEVE WAS MISSING. AFTER CHECKING THE IMAGE, THE SURGEON TRIED TO REMOVE THE FRAGMENT AFTER ALL THE IMPLANTS WERE INSERTED BUT GAVE UP BECAUSE THE FRAGMENT HAD STRAYED INTO THE MUSCLE TISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21002989 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE WHEN THE DOCTOR WAS TAPPING THE LCP 5.0 DRILL GUIDE, THERE WAS A MALFUNCTION AT THE TIP OF THE THREAD. IT BROKE AT THE TIP WHERE IT HAS THREADS THAT STICK TO THE HOLES OF THE THREADED PLATES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SATISFACTORY OUTCOME. THERE WAS NO SURGICAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863661 ↗