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
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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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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