NA 492.16Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20886982236255), received between Apr 9, 2024 and Apr 19, 2024 — classified as 10 injuries.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON 27 MARCH 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19144167 ↗
• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON 27 MARCH 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19143976 ↗
• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO PC-001576402 FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19143658 ↗
• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON 27 MARCH 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO PC-001576402 FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19143513 ↗
• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19143431 ↗
• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON 27 MARCH 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19143352 ↗
• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024 DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON 27 MARCH 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19142421 ↗
• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024.. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON 27 MARCH 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19142313 ↗
• InjuryApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON 27 MARCH 2024. THIS REPORT IS FOR ONE 1.6MM TI KIRSCHNER WIRE 150MM FOR (B)(4). THIS IS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 19142173 ↗
• InjuryApr 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS TO UNDERGO AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE IMPLANTS WERE MISSING FROM THE ORTHOKIT. THE PATIENT WAS UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE INTERVENTION WAS POSTPONED TO (B)(6) 2024. THE ORDERED KIT WAS ENTERED IN THE SYSTEM AND SHIPPED. HOWEVER, THIS KIT CONTAINS ONLY INSTRUMENTATION. THE IMPLANTS ARE IN A DIFFERENT KIT WHICH WAS NOT SHIPPED TO THE CUSTOMER. IT SEEMS THAT THE LOCAL HELPING TOOL FOR THE BOOKING OF ORTHOKIT MISSED SOME INFORMATION; THE HELPING TOOL WAS NOT UPDATED WITH THE CORRECT INFORMATION. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2024. THIS REPORT IS FOR A 1.6MM TI KIRSCHNER WIRE 150MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19070863 ↗