NA 357.36Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982195982), received between Nov 29, 2018 and Nov 16, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON OCTOBER 27, 2023, THAT THE THREADS ON THE EXTRACTOR ARE WORN OUT. A REPLACEMENT EXTRACTOR WAS USED. THERE WAS SURGICAL DELAY FOR TWO MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148704 ↗
• MalfunctionSep 29, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAFF WAS UNABLE TO STERILIZE/ASSEMBLE THE EXTRACTION SCREWS. THERE WAS CHIPPING AND CRACKING, AND THE SCREWS WERE UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE EXTRACTION SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843514 ↗
• MalfunctionSep 11, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720223 ↗
• MalfunctionJun 23, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, WHILE INVENTORYING SETS IT WAS NOTICED THAT SOME INSTRUMENTS WERE AFFECTED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXTRACTION SCREW. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192879 ↗
• MalfunctionMar 27, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE INSTRUMENTS ARE UNABLE TO USE, STERILIZE AND OR ASSEMBLE. CHIPPING AND CRACKING WAS. UNABLE. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. IT WAS UNKNOWN WHEN WAS THE EVENT OCCURRED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622550 ↗
• MalfunctionFeb 8, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT, THE THREAD ON THE EXTRACTION SCREW IN QUESTION WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED SURGICAL DELAY, AND NO ADVERSE PATIENT IMPACT. THIS REPORT IS FOR AN EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323520 ↗
• MalfunctionJan 10, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN INSPECTION AT THE LOANER SET DEPARTMENT IT WAS NOTICED THAT THE EXTRACTION SCREW IN QUESTION WAS USED UP. THERE WAS NO SURGICAL IMPACT AND NO PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131982 ↗
• MalfunctionJan 10, 2023Material Twisted/Bent; Material Twisted/Bent

  THE DEFECTS WERE NOTED DURING REGULAR MAINTENANCE. THERE WAS NO INDICATION FROM THE USER ABOUT LACKING OR FAULTY FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130740 ↗
• MalfunctionJun 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A SPIRAL BLADE WAS STUCK IN ANOTHER ITEM, AN INSTRUMENT. IT WAS FURTHER REPORTED THAT THE INSTRUMENT INVOLVED WAS AN EXTRACTION SCREW. THIS REPORT IS FOR AN EXTRACTION SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009183 ↗
• MalfunctionOct 27, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION, THE EXTRACTION SCREW HAVE FLATTENED. THERE WAS NO PATIENT INVOLVEMENT, THIS REPORT IS FOR ONE (1) EXTRACTION SCREW THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10742655 ↗
• MalfunctionOct 26, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A ROUTINE INSPECTION OF AN INSTRUMENT SET, IT WAS DISCOVERED THAT THE THREADS OF THE NAIL REMOVAL INSTRUMENT ARE DAMAGED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) EXTRACTION SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10737257 ↗
• MalfunctionOct 17, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, AN EXTRACTION SCREW WAS OBSERVED TO BE BROKEN DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204790 ↗
• MalfunctionNov 29, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IT WAS NOTICED THE THREADS ON THE EXTRACTION SCREW WERE DAMAGED, LIMITING THE SCREW FROM FULLY ENGAGING THE INSERTION HANDLE OR NAIL. ISSUE WAS DISCOVERED IN STERILE PROCESSING DEPARTMENT. THERE WAS NOT PATIENT INVOLVEMENT. INVESTIGATION OF THE RETURNED DEVICE REVEALED THE THREADS ARE STRIPPED. CONCOMITANT DEVICE: NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) EXTRACTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8115638 ↗