SPECIALIST 96-6181Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295247210), received between Jul 10, 2018 and Oct 23, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16, 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.

• MalfunctionOct 23, 2023Break; Break

  IT WAS REPORTED THAT THE SIGMA FEMORAL IMPACTOR BROKE INTO TWO PIECES ON IMPACTOR PIECE. NO SURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985526 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17023660 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT THE BOLT BROKE THAT HOLDS THE IMPACTOR TIP TO THE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019953 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED FOLLOWING ITEMS BROKE DURING SURGERY. THE BLACK PLASTIC PART IS DETACHED FROM THE SILVER PART ON TWO OF THE IMPACTORS. THE PART THAT ATTACHES TO THE UNIVERSAL HANDLE HAS SNAPPED OFF OF ANOTHER IMPACTOR. THERE WAS NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581648 ↗
• MalfunctionAug 19, 2022Break; Break

  IT WAS REPORTED THAT THE IMPACTOR IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262209 ↗
• MalfunctionMar 4, 2022Break; Break

  INSTRUMENT BROKE DURING KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13668090 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT BROKEN ATTUNE REVISION FEMORAL IMPACTORS WERE IDENTIFIED BY CSSD. THERE WAS NO SURGEON AFFILIATED WITH THIS EVENT. THE INSTRUMENT IS PART OF A CONSIGNMENT SET AND HAS BEEN TAGGED OUT AND AWAITING COLLECTION FROM HOSPITAL. SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618614 ↗
• MalfunctionMay 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SP*2 FEMORAL IMPACTOR NYL REPL WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778812 ↗
• MalfunctionJan 25, 2021Break; Break

  IT WAS REPORTED THAT THE FEMUR IMPACTOR IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222698 ↗
• MalfunctionApr 30, 2019Naturally Worn; Naturally Worn

  ITEMS WERE FLAGGED DURING THE STERILISATION PROCESS. NO ADVERSE EVENTS REPORTED. NO FURTHER INFORMATION PROVIDED. PHONE DEMONSTRATES THE IMPACTING HEAD IS WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8564730 ↗
• MalfunctionJul 10, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TIBIAL IMPACTOR BROKE IN HALF. ALL PARTS WERE REMOVED. FEMUR IMPACTOR STRIPPED APART. ALL PARTS WERE REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673076 ↗