INHANCE 6507-00-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295549666), received between Nov 9, 2023 and Apr 16, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PILOT ROD GOT STUCK IN SMALL KICKSTAND GUIDE, COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895628 ↗
• MalfunctionApr 8, 2026Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INHANCE KICKSTAND LARGE GUIDE AND PILOT ROD STUCK TOGETHER, AND THE LARGE GUIDE HAS A CRACK NEAR WHERE THE PILOT ROD SLIDES INTO. THIS DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820737 ↗
• MalfunctionJan 24, 2026Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VERSION ROD SNAPPED WHILE TRYING TO CHANGE VERSION, AND THE PILOT ROD WAS CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173627 ↗
• MalfunctionJan 5, 2026Material Deformation

  IT WAS REPORTED THAT DRILL BIT WAS DAMAGED AND FOUND WHILE CROSS THREADING. THIS EVENT HAPPENED IN SURGERY. NO FURTHER INFORMATION IS KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960152 ↗
• MalfunctionFeb 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  INHANCE KICKSTAND THREADED SIZER WILL NOT THREAD FULLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741394 ↗
• MalfunctionNov 9, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT AFTER SURGERY, SALES REP TRIED TO TAKE PILOT ROD OUT OF THE LG KICKSTAND GUIDE HOWEVER THE TWO PIECES WOULD NOT BUDGE AND SEEMED TO BE STRIPPED/STUCK TOGETHER. THIS HAPPENED POST OP SO THERE WAS NO NEGATIVE EFFECT TO THE PATIENT, NOR WAS SURGERY TIME EXTENDED DUE TO THIS. UNFORTUNATELY BECAUSE THE ITEMS DO NOT COME APART, SALES REP WAS UNABLE TO OBTAIN THE LOT NUMBER FROM THE PILOT ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105942 ↗