INHANCE 7000-30-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295538530), received between Jan 19, 2023 and Jan 20, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN STUCK IN RESECTION GUIDE. ANOTHER WAS AVAILABLE AND THE CASE PROCEEDED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123540 ↗
• MalfunctionJun 12, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED. A. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY DAMAGED? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. WHEN THE PIN WAS INSERTED INTO THE RESECTION GUIDE UNDER POWER, IT CREATED METAL SPIRAL FRAGMENTS AS IF THE RESECTION GUIDE HOLE WAS TOO SMALL FOR THE PIN. THE PIN LOOKS MACHINED TO A SMALLER DIAMETER. C. CAN YOU PLEASE CONFIRM THE QUANTITY OF THE RETENTION PIN? 3 FROM THE SAME PACKAGE. - 1 DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106889 ↗
• MalfunctionJun 12, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THIN MACHINED STRANDS OF METAL WERE GETTING DISCHARGED FROM THE PIN - GUIDE INTERFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106836 ↗
• MalfunctionJun 12, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THIN MACHINED STRANDS OF METAL WERE GETTING DISCHARGED FROM THE PIN - GUIDE INTERFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106829 ↗
• MalfunctionJan 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RESECTION GUIDE PIN GOT STUCK (COLDWELDED) IN RESECTION SILHOUETTE GUIDE. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16209824 ↗