LCP 323.029Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982190598), received between Mar 10, 2017 and Apr 27, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE AND LCP DRILL SLEEVE 2.4 W/SCAL-30 F/DRILL B WERE INVOLVED IN AN EVENT. DURING AN ORIF PROCEDURE FOR A DISTAL RADIUS FRACTURE, THE DRILL TIP BROKE OFF, LEAVING APPROXIMATELY 3 MM EMBEDDED IN THE CORTEX. THE TIP WAS EXTRACTED BY MAKING A DORSAL INCISION AND DISASSEMBLING THE AREA. THE DRILL GUIDE WAS DIFFICULT TO REMOVE, SUGGESTING IMPROPER FITTING DURING DRILLING, WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. THERE WAS NO IMPACT TO THE EXPECTED SURGICAL OUTCOME, AND NO PATIENT CONSEQUENCES OR CLINICAL SYMPTOMS WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002055 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A FEW DRILL GUIDES WERE NO LONGER LOCKING INTO THE PLATE. THERE WAS NO PATIENT IMPACT. THIS WAS IDENTIFIED PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714436 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A FEW DRILL GUIDES WERE NO LONGER LOCKING INTO THE PLATE. THERE WAS NO PATIENT IMPACT. THIS WAS IDENTIFIED PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714022 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A FEW DRILL GUIDES WERE NO LONGER LOCKING INTO THE PLATE. THERE WAS NO PATIENT IMPACT. THIS WAS IDENTIFIED PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713933 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A FEW DRILL GUIDES WERE NO LONGER LOCKING INTO THE PLATE. THERE WAS NO PATIENT IMPACT. THIS WAS IDENTIFIED PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713633 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NEUTRAL DRILL GUIDE FOR 4.5 CORTEX SCREW AND THRD LCP(TM) DRILL GUIDE F/LCP(TM) DRPS WERE NOT RETAINING TO THE AIMING ARM DURING USE. BOTH DEVICES DISPLAYED THE SAME ISSUE, DESCRIBED AS THE INABILITY TO PERFORM THEIR INTENDED FUNCTION OF HOLDING ANOTHER DEVICE OR POSITION. THERE WAS NO PATIENT IMPACT, NO REPORTED HARM, AND NO SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559967 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NEUTRAL DRILL GUIDE FOR 4.5 CORTEX SCREW AND THRD LCP (TM) DRILL GUIDE F/LCP (TM) DRPS WERE NOT RETAINING TO THE AIMING ARM DURING USE. BOTH DEVICES DISPLAYED THE SAME ISSUE, DESCRIBED AS THE INABILITY TO PERFORM THEIR INTENDED FUNCTION OF HOLDING ANOTHER DEVICE OR POSITION. THERE WAS NO PATIENT IMPACT, NO REPORTED HARM, AND NO SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559958 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  DEPTH GAUGES TIPS BROKE OFF AND DRILL GUIDE WON'T THREAD INTO PLATE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167391 ↗
• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY TREATING THE DISTAL RADIUS. THE ROTATING PART AT THE BASE OF THE HANDLE DID NOT MOVE WELL, MAKING IT DIFFICULT TO INSERT SCREWS. IT WAS DIFFICULT TO ATTACH THE DRILL SLEEVE IN QUESTION TO THE LOCKING HOLES AND STABILITY COULD NOT BE OBTAINED. WHEN THE DRILL SLEEVE WAS TIGHTENED STRONGLY TO STABILIZE IT, IT BECAME DIFFICULT TO REMOVE FROM THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT, THEIR STATUS IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES. THIS IS REPORT 3 OF 3 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885418 ↗
• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY TREATING THE DISTAL RADIUS. THE ROTATING PART AT THE BASE OF THE HANDLE DID NOT MOVE WELL, MAKING IT DIFFICULT TO INSERT SCREWS. IT WAS DIFFICULT TO ATTACH THE DRILL SLEEVE IN QUESTION TO THE LOCKING HOLES AND STABILITY COULD NOT BE OBTAINED. WHEN THE DRILL SLEEVE WAS TIGHTENED STRONGLY TO STABILIZE IT, IT BECAME DIFFICULT TO REMOVE FROM THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT, THEIR STATUS IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885415 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY TREATING THE DISTAL RADIUS. IT WAS CONFIRMED THAT THE PATIENT HAD BILATERAL FRACTURES OF THE DISTAL ENDS OF THE RADIUS, AND TCP PRODUCTS HAD BEEN USED BILATERALLY. A POSTOPERATIVE X-RAY OF THE RIGHT SIDE SHOWED THAT THE CONTRALATERAL CORTICAL BONE WAS CRACKED WHERE THE CORTEX SCREW WAS INSERTED. THE ROTATING PART AT THE BASE OF THE HANDLE DID NOT MOVE WELL, MAKING IT DIFFICULT TO INSERT SCREWS. IT WAS DIFFICULT TO ATTACH THE DRILL SLEEVE IN QUESTION TO LOCKING HOLES AND STABILITY COULD NOT BE OBTAINED. WHEN THE DRILL SLEEVE WAS TIGHTENED STRONGLY TO STABILIZE IT, IT BECAME DIFFICULT TO REMOVE FROM A PLATE. FOR THE DRILL SLEEVE, IT WAS DIFFICULT TO ATTACH TO LOCKING HOLES AND STABILITY COULD NOT BE OBTAINED. WHEN IT WAS TIGHTENED STRONGLY TO STABILIZE IT, IT BECAME DIFFICULT TO REMOVE FROM A PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS LISTED AS STABLE (B)(4) CAPTURES THE LEFT RADIUS. (B)(4) CAPTURES THE RIGHT RADIUS. (B)(4) TO CAPTURE THE POSTOPERATIVE EVENT ON THE RIGHT SIDE. THIS REPORT IS FOR THREADED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869318 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY TREATING THE DISTAL RADIUS. IT WAS CONFIRMED THAT THE PATIENT HAD HAD BILATERAL FRACTURES OF THE DISTAL ENDS OF THE RADIUS, AND TCP PRODUCTS HAD BEEN USED BILATERALLY. A POSTOPERATIVE X-RAY OF THE RIGHT SIDE SHOWED THAT THE CONTRALATERAL CORTICAL BONE WAS CRACKED WHERE THE CORTEX SCREW WAS INSERTED. THE ROTATING PART AT THE BASE OF THE HANDLE DID NOT MOVE WELL, MAKING IT DIFFICULT TO INSERT SCREWS. IT WAS DIFFICULT TO ATTACH THE DRILL SLEEVE IN QUESTION TO LOCKING HOLES AND STABILITY COULD NOT BE OBTAINED. WHEN THE DRILL SLEEVE WAS TIGHTENED STRONGLY TO STABILIZE IT, IT BECAME DIFFICULT TO REMOVE FROM A PLATE. FOR THE DRILL SLEEVE, IT WAS DIFFICULT TO ATTACH TO LOCKING HOLES AND STABILITY COULD NOT BE OBTAINED. WHEN IT WAS TIGHTENED STRONGLY TO STABILIZE IT, IT BECAME DIFFICULT TO REMOVE FROM A PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS LISTED AS STABLE PC ((B)(6)) CAPTURES THE LEFT RADIUS. PC ((B)(6)) CAPTURES THE RIGHT RADIUS. PC ((B)(6)) TO CAPTURE THE POSTOPERATIVE EVENT ON THE RIGHT SIDE. THIS REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869212 ↗
• MalfunctionAug 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT AN ORIF SURGERY (OSTEOSYNTHESIS) FOR FRACTURE OF DISTAL END OF RIGHT RADIUS. THE SURGEON ATTACHED THE DRILL SLEEVE TO A LOCKING SCREW HOLE OF A PLATE AND DRILLED WITH THE DRILL BIT. A BURR HOLE WAS SUCCESSFULLY MADE, BUT THE DRILL BIT WAS CAUGHT IN THE GAP IN THE DRILL SLEEVE AND COULD NOT BE REMOVED. SINCE THERE WAS ANOTHER DRILL BIT, THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1)THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573405 ↗
• MalfunctionJun 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2018, THE THREADED LOCKING COMPRESSION PLATE (LCP) DRILL GUIDE WAS STRIPPED. THE SURGEON USED A DIFFERENT SCREW IN THE DRILL GUIDE FOR THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7634330 ↗
• MalfunctionMar 10, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE THREADS ON A THREADED LOCKING COMPRESSION PLATE (LCP) DRILL GUIDE WOULD NOT ENGAGE WITH THE HOLE OF THE VARIABLE ANGLE DISTAL RADIUS PLATE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL RADIUS PROCEDURE ON (B)(6) 2017. A SECOND DRILL GUIDE FROM THE SAME SET WAS USED TO PROCEED WITH SURGERY. THE PLATE WAS NOT DAMAGED AND WAS IMPLANTED IN THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A THIRTY SECONDS SURGICAL DELAY. THE DELAY WAS DUE TO GETTING THE SECOND DRILL GUIDE. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE DISTAL RADIUS PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6395189 ↗