LCP 03.108.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982071521), received between May 10, 2017 and Feb 27, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (26 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Device-Device Incompatibility

  IT WAS REPORTED A K-WIRE WAS DIFFICULT TO REMOVE AFTER BEING INSERTED INTO THE LARGE HOLE OF THE AIMING BLOCK. A NEW K-WIRE WAS USED AND THE SAME THING HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471669 ↗
• MalfunctionAug 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT PEDIATRIC VARUS OSTEOTOMY FOR FEMUR WITH THE GUIDING BLOCK. THE SURGEON USED A PLATE, AND DURING THE INSERTION OF THE GUIDEWIRE THROUGH THE GUIDING BLOCK, THE GUIDEWIRE STACKED ON THE WAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. THE DIAMETER OF THE GUIDEWIRE USED WAS APPROPRIATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701698 ↗
• MalfunctionJul 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE 5.0 INSERTER GUIDE WAS BENDING THE 2.0 GUIDE WIRE. SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT. SURGEON PROCEEDED WITHOUT THE GUIDE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545786 ↗
• MalfunctionMay 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE GUIDE WIRE USED TO POSITION THE JIG ONTO THE BONE BECAME WEDGED IN THE CANNULATION OF THE PRODUCT. THE HOSPITAL ARE USING THE APPROPRIATE SIZE AND DIAMETER OF WIRE FOR ITS INTENDED PURPOSE. THE HOSPITAL WERE ABLE TO REMOVE THE WIRE WITH SOME DIFFICULTY. THEY COMPLETED THE OPERATION WITH ANOTHER INSTRUMENT SET AND THERE WAS NO HARM TO THE PATIENT OR DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100287 ↗
• MalfunctionNov 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS A 40 MINUTES SURGICAL DELAY AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795485 ↗
• MalfunctionNov 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE GUIDE WIRE USED TO POSITION THE JIG ONTO THE BONE BECAME WEDGED IN THE CANNULATION OF THE PRODUCT. THIS HAPPENED WITH TWO ITEMS. THE HOSPITAL WAS USING THE APPROPRIATE SIZE AND DIAMETER OF WIRE FOR ITS INTENDED PURPOSE.

  Patient problems: Insufficient Information

  MAUDE report 20698579 ↗
• MalfunctionApr 2, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON MARCH 21, 2024, THE K-WIRE HOLE IN THE GUIDE IS DEFORMED AND WILL NO LONGER TAKE THE APPROPRIATE SIZE WIRE. THE WIRES OFTEN GET JAMMED IN THE HOLE AND BREAK. THIS REPORT INVOLVES ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020687 ↗
• MalfunctionMar 25, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024 THAT DURING THE SURGERY THE SPECIALIST TRIES TO INSERT THE GUIDE WIRE THROUGH THE 5 FOR HIP SCREW GUIDE AND IT GETS STUCK BECAUSE THE HOLE IS DAMAGED, THE SPECIALIST WAS UPSET BECAUSE IT HAS ALREADY HAPPENED SEVERAL TIMES, THE SURGERY WAS NOT DELAYED BECAUSE HE PASSED THE GUIDE WIRE FREEHAND, THE SURGERY WAS SUCCESSFULLY ACHIEVED. PATIENT STATUS/RESULT WAS REPORTED AS SATISFACTORY SINCE HE DID NOT SUFFER ANY NEWS. THIS REPORT IS FOR ONE (1) AIMING BLOCK F/SCR Ø5 F/LCP PAED-HIPPL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968030 ↗
• MalfunctionMar 13, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS FURTHER REPORTED THAT THE SET WAS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894680 ↗
• MalfunctionFeb 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2024, THAT ACCORDING TO THE CUSTOMER'S DESCRIPTION, THE K-WIRE IS JAMMED IN THE TARGET BLOCK DURING AN ONGOING SURGERY. NO PATIENT INFORMATION AVAILABLE. NO PATIENT HARM. SURGERY COMPLETED WITH OTHER DEVICE. THIS REPORT IS FOR ONE (1) AIMING BLOCK F/SCR Ø5 F/LCP PAED-HIPPL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767863 ↗
• MalfunctionFeb 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE WIRE REPEATEDLY PINCHED WHEN PLUGGED IN THROUGH THE GUIDE BLOCK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 10-15 MINUTES. PATIENT OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705324 ↗
• MalfunctionFeb 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS A SURGICAL DELAY OF APPROXIMATELY 10-15 MINUTES. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704781 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE K-WIRE IS JAMMED IN THE TARGET BLOCK DURING AN ONGOING SURGERY. THIS HAD ALREADY HAPPENED TWICE BEFORE (IN 2023), BUT THE TARGET BLOCKS WERE SIMPLY REPLACED BECAUSE IT WAS ASSUMED THAT IT WAS A HANDLING ERROR. NOW THE PROBLEM OCCURRED AGAIN AND, IT WAS NOT A USER ERROR BECAUSE THERE ARE SEVERAL ORS OPERATING IN TWO DEPARTMENTS. THERE WAS NO REPORTED PATIENT HARM. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THIS REPORT INVOLVES ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686840 ↗
• MalfunctionNov 23, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DIRECTIONAL INSTRUMENT FOR 5,0 SCREW BROKE DURING USE. THIS REPORT IS FOR A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852160 ↗
• MalfunctionNov 11, 2022Device-Device Incompatibility; Noise, Audible; Device-Device Incompatibility; Noise, Audible

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT PEDIATRIC ENTROPION OSTEOTOMY FOR COXA WITH THE PRODUCTS IN QUESTION. WHEN INSERTING A 2.8 MM GUIDEWIRE, THE SURGEON USED THE INSTRUMENT IN QUESTION, BUT THERE IS AN ABNORMAL RUBBING NOISE WITH THE INSTRUMENT WHEN INSERTING THE GUIDEWIRE. HERE WAS NO TENSION ON THE GUIDE WIRE, AND WHEN IT WAS ABOUT 3 CM IN, IT WOULD NOT ADVANCE AND COULD NOT BE PULLED OUT. THE GUIDEWIRE BECAME JAMMED IN THE INSTRUMENT, AND THE SURGEON FORCIBLY REMOVED THE INSTRUMENT AND GUIDEWIRE FROM THE BONE. THE INSTRUMENT BECAME UNUSABLE, SO HE CHANGED TO A SMALL STANDARD, INSERTED A GUIDE WIRE, AND APPLIED A PLATE, BUT THE SMALL WAS TOO SMALL FOR THE BONE, SO HE CHANGED AGAIN TO A LARGE STANDARD. SINCE THE INSTRUMENT WAS NOT AVAILABLE, A DRILL GUIDE WITH SCREWS WAS ATTACHED TO THE PLATE AS A SUBSTITUTE FOR THE INSTRUMENT, AND THE GUIDE WIRE WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 40-MINUTE DELAY. THERE WAS A DEFORMATION OBSERVED AT THE TIP OF THE INSTRUMENT HOLE. IT WAS CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT¿S BODY. THE WAS NO PROBLEM WITH BO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779731 ↗
• MalfunctionSep 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY ON (B)(6) 2022, FOR THE PROXIMAL FEMUR. DURING THE PROCEDURE, A GUIDEWIRE WAS NOT ABLE TO PASS THROUGH THE HOLE BECAUSE THE RIGHT HOLE OF THE AIMING BLOCK WAS STIFF. THE SALES REPRESENTATIVE ARRANGED ANOTHER AIMING BLOCK FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494417 ↗
• MalfunctionJun 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS IS DAMAGED. THE HOLE THROUGH WHICH THE GUIDE WIRE PASSES IS DAMAGED, CLOGGED. THERE WAS NO SURGICAL DELAY, NO CHANGE IN SURGICAL METHOD AND NO IMPACT TO THE PATIENT. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14613450 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO K-WIRE DEVICES JAMMED IN EACH GUIDE (03.108.001 AND 03.108.002) AND THE PLATE DEVICE WAS USED AS A GUIDE INSTEAD. IT WAS FURTHER REPORTED THAT DURING REMOVAL OF WIRES LATER, THE EXTENDER ALSO APPEARED DAMAGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) AIMING BLOCK F/SCR Ø5 F/LCP PAED-HIPPL DEVICE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196587 ↗
• MalfunctionDec 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, DURING A PROCEDURE THE INSTRUMENTS BECAME STUCK TOGETHER. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112471 ↗
• MalfunctionSep 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE AIMING BLOCK WAS GOT STUCK A NEEDLE WITH SPADE POINT ONE OF THE HOLES AND MAKE DAMAGE WITH DENT. IT WAS UNKNOWN WHAT TYPE OF PROCEDURE PERFORMED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS THIS REPORT IS 1 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510119 ↗
• MalfunctionSep 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UNKNOWN WIRES WOULD NOT PASS THROUGH TWO (2) PEDIATRIC HIP GUIDING BLOCKS. THE ISSUE WAS DISCOVERED DURING THE ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PPEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421528 ↗
• MalfunctionAug 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE K-WIRE BECAME STUCK IN THE AIMING BLOCK. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365100 ↗
• MalfunctionJul 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE K-WIRE STUCK BECAME STUCK IN THE GUIDE DURING THE PROCEDURE AND WAS NOT ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214142 ↗
• MalfunctionSep 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT UN AN UNKNOWN DATE, WIRES WERE GETTING CAUGHT IN GUIDES. THE GUIDES REQUIRED REPLACEMENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10513784 ↗
• MalfunctionJul 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROXIMAL FEMUR OSTEOTOMY PROCEDURE ON (B)(6) 2020 THE 2MM K-WIRE AS STATED IN THE OP TECHNIQUE GUIDE FITS THROUGH WITH THE SMALL FRAGMENT TARGET BLOCK BUT NOT AS SPECIFIED WITH THE LARGE FRAGMENT TARGET BLOCK. THE HOLE IS TOO SMALL. ACCORDING TO THE SURGICAL TECHNIQUE THIS SHOULD NOT BE THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT KIRSCHNER WIRE, NO OTHER AIMING BLOCK WAS USED. THERE WAS NO SURGICAL DELAY REPORTED. CONCOMITANT DEVICE REPORTED: 2.0MM KIRSCHNER WIRE (PART # 292.790, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254545 ↗