LCP 324.214Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10886982191281), received between Aug 4, 2017 and Sep 29, 2026 — classified as 13 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931500 ↗
• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT WHEN THE DOCTOR DRILLED INTO THE CORTICAL BONE TO INSERT A LOCKING SCREW, HE APPLIED TOO MUCH FORCE, BREAKING THE TIP OF THE DRILL BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536851 ↗
• MalfunctionMay 22, 2026Break

  IT WAS REPORTED DRILL BIT WAS BROKEN ON AN UNKNOWN DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255363 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE DRILL BIT TIP BROKE WITHOUT AFFECTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820036 ↗
• MalfunctionApr 7, 2026Failure to Cut

  IT WAS REPORTED THAT THE 2.8 MM DRILL BIT LACKS A CUTTING EDGE; THEREFORE, IT DOES NOT PERFORM EFFECTIVELY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801514 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT WHILE THE DOCTOR WAS USING THE DRILL BIT TO PERFORATE FROM CORTEX TO CORTEX, FROM A LATERAL TO A MEDIAL APPROACH, AS THE DRILL BIT EMERGED FROM THE MEDIAL END, IT BECAME ENTANGLED IN A GAUZE PAD AND BROKE AT THE TIP. THE TIP REMAINED IN THE PAD BUT NOT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400404 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT Ø2.8 W/SCAL L200/100 3FLUTE F/ WAS BROKEN INTO TWO OR MORE PIECES DURING A PROCEDURE. THE EVENT OCCURRED INTRA-OPERATIVELY WHILE MAKING THE BROCADE OF THE PROXIMAL TIBIA. THE ISSUE WAS RESOLVED BY REMOVING THE BROKEN BIT AND REPLACING IT WITH ANOTHER OF THE SAME TYPE, ALLOWING THE SURGERY TO BE COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT, NO DISCOMFORT TO THE SPECIALIST, AND NO ALTERATION IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804916 ↗
• MalfunctionOct 28, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT WHEN DRILLING WITH A 2.8M DRILL BIT, THE BIT FRACTURED, LEAVING THE TIP OF THE DRILL BIT INSIDE THE PATIENT. THE SPECIALIST EXPERIENCED NO DISCOMFORT. THE SURGERY WAS SUCCESSFUL, AS A SCREW WAS PLACED IN ANOTHER HOLE. THE FRAGMENT REMAINED IN THE PATIENT; IT WAS IMPOSSIBLE TO EXTRACT IT. THE SURGICAL TIME WAS NOT INCREASED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23404198 ↗
• MalfunctionFeb 10, 2025Failure to Cut; Failure to Cut

  IT IS REPORTED THAT THE DRILL BIT IS DULL AND DOES NOT ALLOW PROPER DRILLING.

  Patient problems: Insufficient Information

  MAUDE report 21345559 ↗
• MalfunctionOct 28, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRILL BIT WAS BROKEN AND LEFT INSIDE PATIENT'S TIBIA. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20545541 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL BIT FRACTURED THE TIP DURING THE PROCEDURE ON (B)(6) 2024. THE FRAGMENT WAS MANAGED TO BE EXTRACTED FROM THE PATIENT, WITHOUT COMPLICATIONS. THE SURGERY ENDED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634758 ↗
• MalfunctionMay 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT BREAST IMPLANTATION ON (B)(6) 2024. DURING THE PROCEDURE, THE DRILL BIT #2.8 WAS BROKEN, IN WHICH THE DISTAL END OF THE DRILL BIT REMAINED INSIDE THE PATIENT. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19373953 ↗
• MalfunctionApr 1, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE THE DRILL BROKE. THE DISTAL END OF THE DRILL REMAINS INSIDE THE PATIENT. THIS REPORT INVOLVES ONE (1) 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19013792 ↗
• MalfunctionJan 16, 2024Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT TWO (2) BITS WERE MARKED WITH TAPE AS BENT. ONE OF THESE BITS WAS FOUND WITH STRAND OF HAIR GLUED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18519041 ↗
• MalfunctionAug 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS FOUND THAT THE DRILL BIT IN QUESTION WAS DULL AND WAS STRUGGLING TO CUT THROUGH THE PATIENT¿S BONE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FEW MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576425 ↗
• MalfunctionAug 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS FOUND THAT THE DRILL BIT IN QUESTION WAS DULL AND WAS STRUGGLING TO CUT THROUGH THE PATIENT¿S BONE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FEW MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576392 ↗
• MalfunctionAug 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS FOUND THAT THE DRILL BIT IN QUESTION WAS DULL AND WAS STRUGGLING TO CUT THROUGH THE PATIENT¿S BONE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FEW MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17575766 ↗
• MalfunctionAug 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS FOUND THAT THE DRILL BIT IN QUESTION WAS DULL AND UNABLE TO CUT INTO THE LATERAL CORTEX. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17575413 ↗
• MalfunctionAug 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS FOUND THAT THE DRILL BITS IN QUESTION WERE DULL AND BOTH WERE UNABLE TO CUT INTO THE LATERAL CORTEX. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17575266 ↗
• MalfunctionAug 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS FOUND THAT THE DRILL BITS IN QUESTION WERE DULL AND BOTH WERE UNABLE TO CUT INTO THE LATERAL CORTEX. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17575264 ↗
• MalfunctionAug 7, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT WAS DAMAGED, WHICH HAVE NO NEGATIVE IMPLICATIONS. THIS REPORT IS FOR ONE (1) 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471744 ↗
• InjuryAug 7, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6), 2023, WHEN MANIPULATING THE 2.8 BIT WITH SCALE L200/100, IT SPLIT INSIDE THE BONE. THE FRAGMENT OF THE TIP OF THE DRILL BIT COULD NOT BE REMOVED FROM PATIENT'S LEFT PROXIMAL TIBIA. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17471085 ↗
• MalfunctionJul 25, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6)2022, THE DRILL BIT IN QUESTION WAS FOUND WITH DEFECTS. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388086 ↗
• MalfunctionApr 25, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2023, THAT THERE WERE FAILED EDGES, HAS NO NEGATIVE AFFECTATIONS. THIS ISSUE OCCURRED INTRAOPERATIVELY. THE DRILL BIT WAS DAMAGED WHILE IN USE ON THE PATIENT, BUT DID NOT AFFECT IT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.8 W/SCAL L200/100 3FLUTE F/ THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809094 ↗
• MalfunctionMar 21, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE BITS ARE DULL. CREATES DISCOMFORT WITH THE SPECIALIST. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.8 W/SCAL L200/100 3FLUTE F. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584828 ↗