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LCP 03.120.030Recalls & reported problems

Synthes GmbH · COUPLING BOLT FOR LCP PERIARTICULAR AIMING ARMS · Class 1

All models of LCP (367)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982074270), received between Mar 7, 2019 and May 13, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device-Device Incompatibility6
  • Break1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Patient Involvement2
  • Insufficient Information1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 13, 2025Break; Break

    IT WAS REPORTED THAT ON APR 21, 2025, THE RFNA AIMING ARM BROKE IN DISASSEMBLY. THERE WAS NO SURGICAL DELAY AND NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22012086 ↗
  • MalfunctionMay 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

    ATTEMPTING TO SCREW BOLT FROM VA-LCP CODYLAR AIMING ARM (03.231.003) - BOLT 03.120.030 - INTO INSERTION HANDLE FOR AIMING ARM (03.231.001) - AND WAS NOT THREADING IN. LOOKED LIKE DAMAGED THREAD ON INSERTION HANDLE. FROM LOAN SET (B)(6)- EQUIPMENT NUMBER (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22012046 ↗
  • MalfunctionJun 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2024 THE PRIOR TO THE PROCEDURE, THE SCRUB TECH WAS ASSEMBLING THE AIMING ARM INSTRUMENTS. AFTER DETERMINING THE PLATE TO USE, THE SCRUB TECH CONNECTED THE AIMING ARM INSTRUMENTS TO THE PLATE IN ORDER TO "BUILD THE BOX". THIS WAS UNSUCCESSFUL. AFTER MULTIPLE ATTEMPTS OF DISASSEMBLING AND REASSEMBLING THE AIMING INSTRUMENTS, WE WERE UNABLE TO PROPERLY ALIGN THE AIMING ARM INSTRUMENTS WITH THE PLATE. WE PROCEEDED WITH THE PROCEDURE WITHOUT USING THE AIMING ARM INSTRUMENTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAYS, NEGATIVE OUTCOMES, OR INTERVENTION REQUIRED. AFTER THE PROCEDURE WAS OVER, IT WAS DETERMINED THAT THE AIMING ARM INSTRUMENTATION WAS DEFECTIVE. THIS REPORT IS FOR ONE (1) COUPLING BOLT LCP PERIARTICULAR AIM ARMS THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19630166 ↗
  • MalfunctionJan 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A CASE, THE SURGEON WAS USING AN AIMING ARM, BUT IT DID NOT WORK. IT WAS NOT CONNECTING TO THE TWO PIECES AND IS A BOLT CONNECTING BOLT FOR THE AIMING ARM OF THE PERIARTIC AIM ARM INSTRUMENT THAT CONNECTS BOTH PIECES TOGETHER. IT WAS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES OR OUTCOMES. THIS REPORT IS FOR ONE (1)COUPLING BOLT LCP PERIARTICULAR AIM ARMS THIS IS REPORT 3 OF 3 (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18566776 ↗
  • MalfunctionOct 3, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    IT WAS REPORTED THAT A TRAY WAS DOWN BECAUSE THE THREADS HAD STRIPPED ON TWO PIECES. THE TWO PIECES NO LONGER THREAD TOGETHER AS THEY'RE SUPPOSED AS THEY'RE NO LONGER USABLE. THE PARTS ARE AVAILABLE FOR RETURN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. THIS REPORT IS FOR ONE (1)COUPLING BOLT LCP PERIARTICULAR AIM ARMS THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 17862869 ↗
  • MalfunctionMar 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2019, UPON INSPECTION IN THE STERILE PROCESSING DEPARTMENT (SPD), TWO (2) COUPLING BOLTS APPEARED TO HAVE DAMAGE TO THE STARTING THREADS, AND THE DEVICES COULD NOT BE SCREWED INTO THE AIMING ARM. IT WAS NOTED THAT THE THREADS ON THE AIMING ARM WERE ALSO DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A COUPLING BOLT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8399265 ↗
  • MalfunctionMar 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2019, UPON INSPECTION IN THE STERILE PROCESSING DEPARTMENT (SPD), TWO (2) COUPLING BOLTS APPEARED TO HAVE DAMAGE TO THE STARTING THREADS, AND THE DEVICES COULD NOT BE SCREWED INTO THE AIMING ARM. IT WAS NOTED THAT THE THREADS ON THE AIMING ARM WERE ALSO DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A COUPLING BOLT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8399240 ↗

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