NA 399.43Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886982202819), received between Dec 30, 2016 and Sep 23, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (16 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that the devices are splitting at the handle.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868981 ↗
• MalfunctionSep 23, 2026Break

  It was reported that the devices are splitting at the handle.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868956 ↗
• MalfunctionJun 17, 2024Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HAMMERS HAD LOOSE HANDLES BECAUSE PINS WERE COMING OUT. HAMMERS HAD BEEN IN USE FOR APPROXIMATELY TWO YEAR. THIS REPORT IS FOR A HAMMER 700 GRAMS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19553472 ↗
• MalfunctionJun 17, 2024Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HAMMERS HAD LOOSE HANDLES BECAUSE PINS WERE COMING OUT. HAMMERS HAD BEEN IN USE FOR APPROXIMATELY TWO YEAR. THIS REPORT IS FOR A HAMMER 700 GRAMS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19553401 ↗
• MalfunctionApr 8, 2024Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THAT THE EDGES OF THE HAMMER SURFACE ARE ROLLED. THERE IS A POTENTIAL OF BIOBURDEN AND DEBRIS GETTING CAUGHT BEHIND THE ROLLS OR IN THE CREVICES THAT ARE CREATED. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT SAFETY ISSUE. NO PATIENT HARMED. THIS REPORT IS FOR ONE (1) HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068239 ↗
• MalfunctionAug 7, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE MALLET IN QUESTION HAD BROKEN DURING THE DECONTAMINATION PROCESS IN STERILE PROCESSING. THERE WAS NO REPORTED PROCEDURE OR PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469507 ↗
• MalfunctionMar 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE HAMMER SEEMS TO LEAVE STAINS IN STERI PEEL AFTER BEING STERILIZED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. IT WAS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED OR NOT. IT WAS UNKNOWN IF ANY FRAGMENTS WERE GENERATED. THIS COMPLAIN INVOLVES THREE (3) DEVICE. THIS REPORT IS FOR ONE (1) HAMMER 500 GRAMS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518651 ↗
• MalfunctionMar 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE HAMMER SEEMS TO LEAVE STAINS IN STERI PEEL AFTER BEING STERILIZED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. IT WAS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED OR NOT. IT WAS UNKNOWN IF ANY FRAGMENTS WERE GENERATED. THIS COMPLAIN INVOLVES THREE (3) DEVICE. THIS REPORT IS FOR ONE (1) HAMMER 500 GRAMS THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16517716 ↗
• MalfunctionMay 13, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HAMMER IS DAMAGED. DAMAGE OR FAILURE APPEARS AT PIN CONNECTION POINT IN HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DURING MANUFACTURER'S INVESTIGATION OF THE PROVIDED PHOTO IT WAS OBSERVED THAT THE HAMMER 700 G HAD THE HANDLE BROKEN IN THE PIN AREA. THIS REPORT IS FOR ONE (1) HAMMER 700 GRAMS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14397861 ↗
• MalfunctionMar 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT NEW MALLET HANDLE LOOSE. THIS COMPLAINT INVOLVES ONE (1) DEVICE HAMMER 700 G. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804241 ↗
• MalfunctionOct 18, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HAMMER WAS ORDERED BUT A DIFFERENT HAMMER WAS DELIVERED. THE HEAD PART MAY BE THE SAME BUT THE HANDLE IS DIFFERENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648230 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HAMMER WAS BEING USED AND THE HANDLE BROKE. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609501 ↗
• MalfunctionNov 5, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON UNKNOWN DATE IN 2018, THREE (3) MALLETS WERE OPENED AND APPEARED TO BE LEACHING SOME SORT OF GREASE OR OIL THAT SEEMED TO COME FROM A GAP BETWEEN THE METAL SHAFT AND THE WOOD HANDLE. THE MALLETS WERE REMOVED FROM THE STERILE FIELD AND REPLACEMENT MALLETS WERE SUPPLIED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMER 700 GRAMS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040223 ↗
• MalfunctionNov 5, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON UNKNOWN DATE IN 2018, THREE (3) MALLETS WERE OPENED AND APPEARED TO BE LEACHING SOME SORT OF GREASE OR OIL THAT SEEMED TO COME FROM A GAP BETWEEN THE METAL SHAFT AND THE WOOD HANDLE. THE MALLETS WERE REMOVED FROM THE STERILE FIELD AND REPLACEMENT MALLETS WERE SUPPLIED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMER 700 GRAMS. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040215 ↗
• MalfunctionNov 5, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON UNKNOWN DATE IN 2018, THREE (3) MALLETS WERE OPENED AND APPEARED TO BE LEACHING SOME SORT OF GREASE OR OIL THAT SEEMED TO COME FROM A GAP BETWEEN THE METAL SHAFT AND THE WOOD HANDLE. THE MALLETS WERE REMOVED FROM THE STERILE FIELD AND REPLACEMENT MALLETS WERE SUPPLIED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMER 700 GRAMS. THIS IS REPORT 1 OF 3 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040201 ↗
• MalfunctionAug 20, 2018Break; Break

  IT WAS REPORTED THAT DURING STERILE PROCESSING ON UNKNOWN DATE, IT WAS NOTICED THAT THE HAMMER HANDLE BROKE. NO SURGICAL INVOLVEMENT WAS NOTED. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7796568 ↗
• MalfunctionMay 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THREE (3) 700GRAM HAMMERS ARE LEAVING GREASY RESIDUE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A HAMMER 700 GRAMS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7508630 ↗
• MalfunctionMay 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THREE (3) 700GRAM HAMMERS ARE LEAVING GREASY RESIDUE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A HAMMER 700 GRAMS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7508626 ↗
• MalfunctionMay 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THREE (3) 700GRAM HAMMERS ARE LEAVING GREASY RESIDUE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A HAMMER 700 GRAMS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7508622 ↗
• MalfunctionMay 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE MALLETS ARE LEAVING A GREASY RESIDUE IN THE PANS. THIS DISCOVERY WAS MADE BY THE MEDICAL REPROCESSING STAFF AND REPORTED TO THE SALES CONSULTANT. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. IT IS UNKNOWN EXACTLY HOW AND WHEN THE DISCOVERY WAS MADE. THIS REPORT INVOLVES 3 DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7485575 ↗
• MalfunctionMay 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE MALLETS ARE LEAVING A GREASY RESIDUE IN THE PANS. THIS DISCOVERY WAS MADE BY THE MEDICAL REPROCESSING STAFF AND REPORTED TO THE SALES CONSULTANT. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. IT IS UNKNOWN EXACTLY HOW AND WHEN THE DISCOVERY WAS MADE. THIS REPORT INVOLVES 3 DEVICES. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7485571 ↗
• MalfunctionMay 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE MALLETS ARE LEAVING A GREASY RESIDUE IN THE PANS. THIS DISCOVERY WAS MADE BY THE MEDICAL REPROCESSING STAFF AND REPORTED TO THE SALES CONSULTANT. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. IT IS UNKNOWN EXACTLY HOW AND WHEN THE DISCOVERY WAS MADE. THIS REPORT INVOLVES 3 DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7485570 ↗
• MalfunctionApr 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT STAFF NOTICED A YELLOWISH, GREASY MATERIAL COMING OUT OF THE WOOD/METAL INTERFACE OF A SYNTHES HAMMER 700 GRAMS DEVICE AFTER STERILIZATION. THE STAFF CONDUCTED A SWAB TEST TO CHECK FOR THE PRESENCE OF PROTEINS AND THE TEST CAME BACK AT 50 (UNKNOWN UNIT OF MEASURE). THE TEST¿S ALLOWABLE LIMIT IS 45 AND UNDER AND THE HOSPITAL AIMS FOR A MEASURE OF 10 OR LESS. THE HAMMER IS PROPERLY CLEANED AND STERILIZED AND THE ¿YELLOWISH GREASE¿ KEEPS APPEARING AFTER STERILIZATION. THERE WERE NO BROKEN PIECES FROM THE DEVICE AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7409527 ↗
• MalfunctionMay 4, 2017Residue After Decontamination; Device Contamination with Chemical or Other Material; Residue After Decontamination; Device Contamination with Chemical or Other Material

  NEITHER PATIENT HAD RECEIVED ANY PREOPERATIVE MEDICATION. THE 45 MINUTES DELAY WAS IDENTIFIED DURING THE SET UP FOR THE SURGERIES AND IT WAS KNOWN WELL BEFORE THE SCHEDULED START TIME FOR EACH PROCEDURE. IT WAS ALSO IDENTIFIED THAT THE WOODEN HANDLE FOUND DURING THE SURGERY SET UP FOR (B)(4) WAS BROKEN IN TWO PIECES.

  Patient problems: No Patient Involvement

  MAUDE report 6546562 ↗
• MalfunctionMay 4, 2017Residue After Decontamination; Device Contamination with Chemical or Other Material; Residue After Decontamination; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE SETTING UP FOR TWO SURGERIES OCCURRING AT THE SAME TIME ON AN UNKNOWN DATE, GREASE WAS NOTED IN THE HIP TRAY AT THE SITE OF THE MALLET. NEITHER PATIENT WAS IN THE OPERATING ROOM AT THE TIME. AS AN IMMEDIATE RESPONSE, 26 HIP TRAYS WERE RE-STERILIZED WITHOUT THE MALLETS INCLUDED AND NO FURTHER GREASE WAS NOTED. THE 26 MALLETS WERE STERILIZED SEPARATELY IN PEEL PACKS AND GREASE WAS NOTED WITHIN THE PACKAGING. IT WAS REPORTED THAT THERE WAS A 45 MINUTE DELAY IN STARTING EACH SURGERY BECAUSE OF THE NEED TO RE-STERILIZE THE DEVICES. A COMPETITOR¿S MALLET WAS USED IN BOTH SURGERIES DUE TO THE CONTINUED IDENTIFICATION OF GREASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. RELATED COMPLAINTS (B)(4) CAPTURES THE REPORT OF THE FIRST AND SECOND SURGERIES THAT WERE POSTPONED FOR 45 MINUTES. THIS COMPLAINT CAPTURES THE REMAINING 24 MALLETS. THIS REPORT IS 7 OF 24 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6546549 ↗