NA 2001-80-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295080145), received between Apr 23, 2019 and Jun 6, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT THE SPIKE FROM THE END OF THE IM INITIATOR SIZED SNAPPED OFF DURING PROCESSING. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162019 ↗
• MalfunctionApr 19, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THE INSTRUMENT WAS DAMAGED (BLUNT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773886 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT THE SHARP TIP FOR THE IM INITIATOR BROKE OFF IN THE FEMUR OF THE PATIENT. THE TIP WAS RECOVERED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533604 ↗
• MalfunctionJul 22, 2020Dull, Blunt; Dull, Blunt

  AFTER CHECKING, THE FOLLOWING DIVERGENCE WAS DETECTED: CODE: 253151000 LOT IN N.F: N72697 (IT PRESENTS SPLINTERS). CODE: L20504 LOT IN N.F: 9799167 (CRACKED COVER).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310836 ↗
• MalfunctionMay 28, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE POINTED TIP AT THE END OF THE IM INITIATOR WAS BENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10098359 ↗
• MalfunctionApr 23, 2019Dull, Blunt; Dull, Blunt

  SURGEON INDICATED THAT THE PRODUCT (200180501) HAS BECOME DULL AND HAS REQUESTED A REPLACEMENT. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8540692 ↗