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LCP 03.108.001Recalls & reported problems

Synthes GmbH · PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS · Class 1

All models of LCP (367)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Synthes pediatric hip plate guiding block is a surgical instrument used to position screws. The 26 reports mostly describe guide wires getting stuck or wedged inside the block, sometimes requiring extra force or a different instrument set to finish the procedure, with no deaths and no injuries mentioned. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
25
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886982071514), received between Sep 10, 2020 and Aug 8, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (25 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device-Device Incompatibility25
  • Break2
  • Mechanical Jam2

Patient problems

  • No Clinical Signs, Symptoms or Conditions20
  • Insufficient Information4
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT 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, BUT WANT THE ITEM TO BE SENT OFF FOR ANALYSIS. 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 22756679 ↗
  • MalfunctionFeb 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE TIMING OF THE REPORTED EVENT WAS DURING POST-OP. THE OPERATION WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT INSTRUMENT SET. NO OTHER COMPLAINT NEEDS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 21460880 ↗
  • 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 20698491 ↗
  • MalfunctionAug 7, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE BECAME STUCK IN THE TARGET. THIS HAPPENED PREVIOUSLY WITH THREE OTHER TARGETS. THIS REPORT IS FOR A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 19932485 ↗
  • MalfunctionFeb 1, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE 2.8 GUIDE WIRE FOR THE AIMING BLOCK WAS STUCK INSIDE THE GUIDE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) AIMING BLOCK F/SCR Ø3.5 F/LCP PAED-HIPPL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 18627603 ↗
  • MalfunctionJan 30, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A CORRECTIVE OSTEOTOMY FOR A VARUS DEFORMITY OF THE PROXIMAL FEMUR. THE SURGEON INSERTED THE GUIDEWIRE USING THE AIMING BLOCK. WHEN THE SURGEON TRIED TO PULL OUT THE GUIDEWIRE TO ADJUST ITS POSITION, IT GOT STUCK IN THE AIMING BLOCK AND COULD NOT BE PULLED OUT OR INSERTED. THE SURGERY WAS PERFORMED BY OTHER TECHNIQUES AND WAS COMPLETED WITHOUT PROBLEMS WITHIN A 30 MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18607225 ↗
  • MalfunctionMay 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

    THE EVENT OCCURRED INTRA-OP, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17030807 ↗
  • MalfunctionFeb 22, 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 UNKNOWN SURGERY WITH THE GUIDE WIRE AND THE AIMING BLOCK. WHILE TRYING TO INSERT THE WIRE WITH THE AIMING BLOCK, THE SURGEON WAS ABLE TO INSERT THE WIRE INTO THE RIGHT HOLE WITH NO PROBLEM. HOWEVER, THE WIRE DID NOT PASS THROUGH THE LEFT HOLE SMOOTHLY. ALTHOUGH ONCE THE WIRE WAS INSERTED FORCEFULLY, THE WIRE COULD NOT BE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES SURGICAL DELAY. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16422041 ↗
  • MalfunctionOct 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: IT WAS REPORTED THAT THE LG PED LCP HIP PL GUIDING BLOCK FAILED. THIS PARALLEL GUIDE HAD TROUBLE PASSING THE K NEEDLE. THERE WAS NO SURGICAL DELAY DUE TO THE EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO. THIS REPORT IS FOR ONE (1) LG PED LCP HIP PL GUIDING BLOCK 3.5 SCRS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15631299 ↗
  • MalfunctionSep 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICE DID NOT ALLOW K-WIRES TO PASS THROUGH THE HOLE. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15393288 ↗
  • MalfunctionSep 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 2.8 WIRE HAS WELDED INTO THE GUIDE BLOCK HOLES, THIS IS THE 4TH TIME THIS HAS HAPPENED. ANOTHER SET OPENED. 30 MINUTE DELAY IN SURGERY. NO PATIENT IMPACT. THIS REPORT IS FOR A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15335980 ↗
  • MalfunctionSep 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 2.8 WIRE HAS WELDED INTO THE GUIDE BLOCK HOLES, THIS IS THE 4TH TIME THIS HAS HAPPENED. ANOTHER SET OPENED. 30 MINUTE DELAY IN SURGERY. NO PATIENT IMPACT. THIS REPORT IS FOR A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15335707 ↗
  • MalfunctionAug 31, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE 2.8 WIRE HAS WELDED INTO THE GUIDE BLOCK HOLES, THIS IS THE 4TH TIME THIS HAS HAPPENED. ANOTHER SET OPENED.30 MINUTE DELAY IN SURGERY. NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) AIMING BLOCK F/SCR Ø3.5 F/LCP PAED-HIP PL . THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15331326 ↗
  • MalfunctionAug 31, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT 2.8 WIRE HAS WELDED INTO THE GUIDE BLOCK HOLES, THIS IS THE 4TH TIME THIS HAS HAPPENED. ANOTHER SET OPENED.30 MINUTE DELAY IN SURGERY. NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1)AIMING BLOCK F/SCR Ø3.5 F/LCP PAED-HIPPL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15328276 ↗
  • MalfunctionAug 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THERE WAS DIFFICULTY IN GETTING THE AIMING BLOCK TO ATTACH. THE SURGEON OPENED ANOTHER INSTRUMENT TRAY. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15312678 ↗
  • MalfunctionAug 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A DEFECT IN THE GUIDING BLOCK. BEFORE SURGERY, ON (B)(6) 2022, A STAFF FOUND THAT A GUIDE WIRE COULD PASS THROUGH THE RIGHT HOLE OF THE GUIDING BLOCK WHILE THE GUIDE WIRE GOT STUCK IN THE LEFT HOLE OF THE GUIDING BLOCK. THEREFORE, ANOTHER GUIDING BLOCK WAS SHIPPED AS A SUBSTITUTE. THE HOSPITAL REQUESTED THOROUGH INSPECTION BEFORE SHIPMENT. THE SAME KIND OF EVENT OCCURRED AT THIS HOSPITAL WAS REPORTED IN (B)(4). SINCE THEN, THE HOSPITAL STARTED TO CHECK GUIDING BLOCKS BEFORE SURGERY. THIS REPORT IS FOR ONE (1) AIMING BLOCK F/SCR Ø3.5 F/LCP PAED-HIPPL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15216617 ↗
  • MalfunctionMay 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT ONE OF THE HOLES IN THE GUIDE DID NOT ALLOW THE PASSAGE OF THE NEEDLE INDICATED FOR THE PROCEDURE WHILE THE SYSTEM LOCKING SCREW WAS ROLLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14464840 ↗
  • MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 4 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 Ø3.5 F/LCP PAED-HIPPL DEVICE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14196549 ↗
  • MalfunctionFeb 22, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

    IT WAS REPORTED THAT ON UNKNOWN DATE, DURING CLEANING, IT WAS NOTICED THAT THE K-WIRE WOULD NOT PASS THROUGH THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13578985 ↗
  • MalfunctionOct 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT BEFORE THE SURGERY, IT WAS CONFIRMED THAT THE KIRSCHNER WIRE WAS STUCK AND COULD NOT BE INSERTED SMOOTHLY WHEN THE SURGEON INSERTED THE KIRSCHNER WIRE 2.8 INTO THE AIMING BLOCK. DURING THE SURGERY, THE SURGEON RE-INSERTED THE KIRSCHNER WIRE 2.8 INTO THE AIMING BLOCK SEVERAL TIMES, AND AS A RESULT, NO EVENTS OCCURRED IN WHICH THE KIRSCHNER WIRE COULD NOT BE REMOVED FROM THE AIMING BLOCK. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12579402 ↗
  • MalfunctionSep 30, 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 PATIENT UNDERWENT THE OPEN REDUCTIONAL INTERNAL FIXATION SURGERY FOR PROXIMAL FEMUR WITH THE AIMING BLOCK AND 2.8MM KIRSCHNER WIRE. DURING THE SURGERY WITH LOCKING COMPRESSION PLATE (LCP) PEDIATRIC HIP PLATE, THE SURGEON SMOOTHLY COMPLETED THE PROCEDURE OF PASSING THE POSITIONING WIRE 2.0MM THROUGH THE POSITIONER FOR AIMING BLOCK AND PROCEEDED TO THE NEXT STEP, THE STEP OF PASSING THE KIRSCHNER WIRE 2.8MM THROUGH THE AIMING BLOCK, BUT THERE WAS A FEELING OF DISCOMFORT WHEN INSERTING THE KIRSCHNER WIRE 2.8MM AND HARD TO INSERT. HOWEVER, IT WAS FORCEFULLY INSERTED. AS A RESULT OF FORCED INSERTION, KIRSCHNER WIRE 2.8MM COULD NOT BE REMOVED FROM THE AIMING BLOCK AND THE SURGEON DECIDED NOT TO USE THEM. THE SURGERY WAS PERFORMED FREEHAND BY THE SURGEON AND WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. THE PATIENT OUTCOME IS REPORTED AS STABLE. THE SURGEON COMMENTED THAT HE PREVIOUSLY EXPERIENCED DISCOMFORT WHEN INSERTING KIRSCHNER WIRE 2.8 MM INTO THE AIMING BLOCK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE GUIDING BLOCK F

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12556679 ↗
  • 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) PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12421527 ↗
  • MalfunctionAug 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE VARUS OSTEOTOMY SURGERY WITH THE AIMING BLOCK. DURING THE SURGERY, WHEN THE SURGEON TRIED TO PASS THE GUIDE WIRE THROUGH THE AIMING BLOCK, THE GUIDE WIRE WAS NOT PASSED. THE SURGEON USED ANOTHER DEVICE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. AFTER THE SURGERY, A PERSON TRIED TO PASS OTHER GUIDE WIRE THROUGH THE AIMING BLOCK, BUT THE GUIDE WIRE WAS NOT PASSED. THE PATIENT IS REPORTABLE STABLE AFTER THE PROCEDURE. THIS REPORT IS FOR AN AIMING BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12353704 ↗
  • MalfunctionJun 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE, AN ISSUE WAS EXPERIENCED WITH THE AIMING BLOCK; ONE OF THE HOLES FOR THE PIN OF 2.8 MM WAS CLOGGED MAKING IT IMPOSSIBLE TO INSERT THE PIN THROUGH THE GUIDE. DESPITE SEVERAL ATTEMPT TO CLEAN THE DEVICE DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO PERFORM THE PASSAGE WITH A PIN OF THE REQUIRED SIZE (I.E., 2.8 MM) IN THE HOLE OF THIS GUIDE. IT APPEARS THAT THE PRODUCT WAS DELIVERED LIKE THAT TO THE CUSTOMER, HOWEVER, IT IS NOT POSSIBLE TO KNOW IF THE ISSUE OCCURRED DURING A PROCEDURE OR IF THE DEVICE WAS DAMAGED BEFORE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A PEDIATRIC LOCKING COMPRESSION PLATE (LCP) HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12092335 ↗
  • 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 LOCKING COMPRESSION PLATE (LCP) HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10513732 ↗

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