NA 2178-30-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295094012), received between Mar 11, 2019 and Mar 13, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS DEVICE GOT STUCK IN THE PIN PULLER. THE END THAT GOT STUCK APPEARED TO BE DAMAGED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893252 ↗
• MalfunctionDec 13, 2022Break; Material Deformation; Break; Material Deformation

  PINS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966450 ↗
• MalfunctionDec 13, 2022Break; Material Deformation; Break; Material Deformation

  PINS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966338 ↗
• MalfunctionDec 13, 2022Break; Material Deformation; Break; Material Deformation

  PINS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966259 ↗
• MalfunctionDec 13, 2022Break; Material Deformation; Break; Material Deformation

  PINS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966255 ↗
• MalfunctionNov 20, 2022Break; Break

  INSTRUMENT BROKE DURING KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831546 ↗
• MalfunctionNov 18, 2022Break; Break

  INSTRUMENT BROKE DURING KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828028 ↗
• MalfunctionNov 19, 2021Naturally Worn; Naturally Worn

  IT SHOULD BE NOTED THAT ALL PRODUCT HAS NOT FAILED, IT HAS WORN OUT DUE TO MULTIPLE USE OR A NUMBER OF YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843767 ↗
• MalfunctionMar 5, 2020Material Twisted/Bent; Naturally Worn; Scratched Material; Material Twisted/Bent; Naturally Worn; Scratched Material

  CONTACTED BY HOSPITAL REQUIRING REPLACEMENT INSTRUMENTS FOR WORN/DAMAGED CONSIGNMENT INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793816 ↗
• MalfunctionOct 17, 2019Break; Break

  TIBIAL PIN BROKE WHILE TRYING TO REMOVE FROM THE TIBIAL TRAY DUE TO THE PATIENT HAVING REALLY HARD BONE. NO AE REPORTED. 10 MINUTES DELAY. ACTION TAKEN: GRABBED THE REMAINING PIECE OF PIN USING NEEDLE NOSE PLIERS.

  Patient problems: Not Applicable

  MAUDE report 9202881 ↗
• MalfunctionMar 11, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TIBIAL TRAY PIN GOT STUCK IN THE PIN HOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407566 ↗