NA 332.175Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982192660), received between Sep 11, 2020 and Dec 8, 2022 — classified as 2 malfunctions.

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

• MalfunctionDec 8, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE 332.175 CAPOS CHISEL DAMAGED, END OF THE BLADE HAS DENTS, THROUGH ROUTINE USE. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO. PATIENT STATUS/OUTCOME/CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1)SEAT-CHISEL CANN Ø2 F/CHILD-HIP-PL 4.5+F. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939109 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2020, THE SURGEON ATTEMPTED TO PUT THE CUTTING GUIDE ON THE CHISEL VIA THE BLUNT END AND IT WOULD NOT GO ON. UPON INSPECTION EACH OF THE THREE CHISELS WERE FOUND TO HAVE BURRED ENDS AS A RESULT OF HAMMER BLOWS TO INSERT THE CHISEL INTO BONE. THE SURGEON DECIDED TO NOT USE THE CUTTING GUIDE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN CUTTING GUIDE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521880 ↗