NA 211311Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705001590), received between Jun 25, 2024 and Jul 10, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF FOUR (4) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711464 ↗
• MalfunctionJul 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 3 OF 4 FOR(B)(4). IT WAS REPORTED THAT AN ORDER OF FOUR (4) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711445 ↗
• MalfunctionJul 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF FOUR (4) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711352 ↗
• MalfunctionJul 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF FOUR (4) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711240 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 8 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604788 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 10 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604697 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 9 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604666 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 7 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604496 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 6 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604437 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 5 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604364 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 4 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604337 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 3 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604288 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 1 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604276 ↗
• MalfunctionJun 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 2 OF 10 FOR (B)(4). IT WAS REPORTED THAT AN ORDER OF TEN (10) TROCAR POINT GUIDE PIN DEVICES WAS RECEIVED, AND IT WAS OBSERVED THAT THE LOT NUMBERS PRINTED ON THE OUTSIDE OF THE PACKAGES DIFFERED FROM THOSE PRINTED ON THE INSIDE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604262 ↗