Novation 167-02-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862036025), received between Oct 30, 2020 and Nov 8, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K080980); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE SPRINGS ON THE LOCKING MECHANISM OF THE BROACH HANDLE HAVE BROKEN. THIS HAS HAPPENED OVER TIME BY HEAVY STRIKES WITH THE MALLET AND CARELESS BEHAVIOR IN CENTRAL STERILE. THE SPRINGS AND LOCKING MECHANISMS ARE DAMAGED ON THE HANDLES. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752898 ↗
• MalfunctionFeb 9, 2022Break; Break

  AS REPORTED, DURING IMPACTION, THE SPRING ON THE BROACH HANDLE WAS BROKEN BY SURGEON. THIS SITUATION CAME TO NO SURPRISE BECAUSE THIS HAS HAPPENED TO SURGEON ON NUMEROUS OCCASIONS USING A PLUS SIZED MALLET WHILE BROACH FEMUR. THIS INCIDENT CAUSED NO DELAY, THE SURGICAL SITE WAS CONFIRMED CLEAN BY SURGEON AND THE PROCEDURE CARRIED ON AS PLANNED. PATIENT IS STABLE CONDITION. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500541 ↗
• InjuryDec 18, 2020Break; Break

  SURGEON BROKE THE SPRING IN THE HANDLE DURING IMPACTION. THE PATIENT WAS NOT AFFECTED. THERE WAS NO HARM TO THE PATIENT. THE CASE WENT ON AS PLANNED WITH NO ISSUE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT IN STABLE CONDITION AND NOT AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11036121 ↗
• MalfunctionOct 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  BROACH HANDLES SPRING WAS BROKEN DURING IMPACTION. PATIENT WAS NOT HARMED. HAD TWO HANDLES IN THE ROOM. NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10762947 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080980. One submission often covers many models, so check the product and lot details in each record.

• Z-0201-2016 · Sep 23, 2015 · Terminated
  Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation