NA 03.113.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982072917), received between May 1, 2017 and Jun 28, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON JUNE 3, 2024, THE SALES CONSULTANT WAS NOTIFIED BY CPD STAFF THAT THE SCREW THAT GOES INTO THE CONNECTING ARM WAS NOT SCREWING BACK IN. THE THREADS APPEAR TO BE STRIPPED AND WAS PROBABLY A RESULT OF MULTIPLE ATTEMPTS TO FIX. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR AN INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638540 ↗
• MalfunctionApr 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE AIMING ARM FOR THE LOCKING COMPRESSION (LCP) LOW BEND MEDIAL DISTAL TIBIA PLATE WAS NOT LINING UP WITH THE PLATE PROPERLY. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610360 ↗
• MalfunctionMar 12, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475469 ↗
• MalfunctionDec 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN LCP MEDIAL DISTAL TIBIA INTERNAL FIXATION WITH JIG PROCEDURE, THE AIMING ARM AND INSERTION HANDLE DID NOT ALIGN WITH LCP HOLES. THE SURGEON WAS UNABLE TO USE THESE INSTRUMENTS FOR PERCUTANEOUS INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN TIBIAL PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102229 ↗
• MalfunctionJun 18, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT DURING SERVICE EVALUATION, THE SCREW OF A PERCUTANEOUS INSERTION HANDLE FOR AIMING ARM (RIGHT) WAS FOUND MISSING AND MIGHT REQUIRE REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7610733 ↗
• MalfunctionMay 24, 2018Component Missing; Component Missing

  (B)(6) REPORTED FOLLOWING: IT WAS REPORTED THAT WHILE GOING THROUGH THE WASHING MACHINE DURING STERILIZATION, THE SCREW THAT TIGHTENS THE INSERTION HANDLE TO THE AIMING ARM MUST HAVE LOOSENED. IT WAS LOST AND COULD NOT BE LOCATED. THERE WAS NO SURGERY OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7542471 ↗
• MalfunctionJun 7, 2017Component Missing; Component Missing

  IT WAS REPORTED THAT AN INSERTION SCREW FOR AN INSERTION HANDLE IS MISSING. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6619838 ↗
• MalfunctionMay 1, 2017Component Missing; Component Missing

  IT IS REPORTED THE INSERTION HANDLE IS MISSING THE CONNECTION SCREW COMPONENT. ISSUE WAS DISCOVERED DURING INSPECTION OF THE DEVICE. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSERTION HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6533556 ↗