NA 03.010.056Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886982067289), received between Jan 16, 2019 and Jun 19, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  SLIDING NUT IS STUCK ON THE SHAFT OF THE HAMMER. IT PREVENTS THE INSTRUMENT FROM BEING USED PROPERLY. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292516 ↗
• MalfunctionAug 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A REMOVAL SURGERY. BEFORE THE SURGERY, THE PRODUCTS IN QUESTION WERE STERILIZED BY HIGH-PRESSURE STEAM. WHEN THE STERILIZATION WAS PERFORMED, BROWN DIRT-LIKE STAINS BLOTTED OUT THE INSIDE OF THE COVERING CLOTH. STERILIZATION WAS PERFORMED AT TEMPERATURE: 135°C, STERILIZATION: 10 MINUTES, DRYING: 50 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20012333 ↗
• MalfunctionAug 20, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTED PATIENT HARM. AND THAT THE SURGERY ENDED WITHOUT ANY TROUBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001536 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE, WHILE USING THE SLAP HAMMER IN QUESTION THE WOODEN HANDLE OF THE HAMMER BROKE AND SHATTERED INTO PIECES. ALL GENERATED FRAGMENTS WERE FOUND AND REMOVED WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE.THIS REPORT IS FOR A SLIDE/FIXED HAMMER 700 GRAMS.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387355 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE, WHILE USING THE SLAPP HAMMER IN QUESTION THE WOODEN HANDLE OF THE HAMMER BROKE AND SHATTERED INTO PIECES. ALL GENERATED FRAGMENTS WERE FOUND AND REMOVED WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384203 ↗
• MalfunctionApr 5, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING STERILE PROCESS DEPARTMENT, A 2.5 HEX SCREWDRIVER WAS OBSERVED AS STRIPPED. WON'T BE ABLE TO INSERT SCREWS WITHOUT STRIPPING HEAD OF SCREW. ALSO, A SLIDE HAMMER'S HANDLE WAS OBSERVED AS CRACKED, BROKEN AND UNUSABLE. NONE WERE USED IN SURGERY LATELY JUST OBSERVED AS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SLIDE/FIXED HAMMER 700 GRAMS THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685447 ↗
• MalfunctionDec 19, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING CLEANING SIDE OF SPD, IT WAS FOUND THAT THE SLIDE/FIXED HAMMER 700 GRAMS HANDLE WAS BROKEN. THIS REPORT IS FOR ONE (1) SLIDE/FIXED HAMMER 700 GRAMS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010711 ↗
• MalfunctionNov 29, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882272 ↗
• MalfunctionSep 2, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE BUILDING THE SET THE SALES REP NOTICED THAT THE HANDLE WAS BROKEN. THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351832 ↗
• InjuryJul 20, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ETN SET MARKED FOR ETN PIN EXTRACTION. ALSO SENT ILN UNIVERSAL PIN EXTENSION SET. IT WAS SENT FROM ILN, AND INSTEAD OF SENDING THE ETN EXT SET SENT THE SET OF EXT BROKEN PINS. ANESTHETIZED PATIENT AND SURGEON WITHOUT MATERIAL TO EXTRACT THE PIN .SURGERY TOOK LONG, OPENED SETS AND SETS OF MATERIAL TO TRY TO FIND A SOLUTION THAT ALLOWED THE IMPLANT TO BE REMOVED. DAMAGED PARTS BELONGING TO OTHER INSTRUMENTS. THE PRODUCT COMPLAINT (B)(4) WAS OPENED ON (B)(6) 2022, FOR A DAMAGED PRODUCT. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)COMBINED HAMMER 700G CAN BE MOUNTED F/35. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15065107 ↗
• MalfunctionJul 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 WHEN STRIKING THE DRIVING CAP TO INSERT THE NAIL INTO THE MEDULLARY CANAL, A PIECE OF THE HANDLE ON THE HAMMER BROKE OFF. THERE WAS A PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961223 ↗
• MalfunctionFeb 16, 2021Break; Break

  THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334872 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING INSERTION OF A TIBIAL NAIL IN ACCORDANCE WITH PROPER TECHNIQUE, THE COMBINED HAMMER HANDLE SPLIT. THE COMBINED HAMMER WAS PASSED OFF THE FIELD AND A DIFFERENT HAMMER WAS USED FOR CONTINUED INSERTION OF THE NAIL WITHOUT PROCEDURE INTERRUPTION. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267853 ↗
• MalfunctionFeb 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLIDE/FIXED HAMMER FOR TIBIA NAIL SET WOULD NOT SCREW DOWN, IT STAYED LOCKED. THE HAMMER DID NOT FIT IN THE GRAPHIC CASE AND CANNOT BE USED. THERE WAS AN UNKNOWN NUMBER SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: CASES/TRAYS/MODULES (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1) THIS REPORT INVOLVES ONE (1) SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11265544 ↗
• MalfunctionAug 27, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL. DURING THE PROCEDURE, A SLIDE/FIXED HAMMER FELL OFF THE HANDLE. ANOTHER SLIDE/FIXED HAMMER WAS USED TO FINISH THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460476 ↗
• MalfunctionJun 11, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR RIGHT TIBIA DIAPHYSIS FRACTURES USING THE EXPERT TIBIAL NAIL SYSTEM. BEFORE THE SURGERY THE HOSPITAL FOUND THAT THE CASE HAD BEEN TAINTED IN A BROWN COLOR. LATER, THEY FOUND THAT THE DISPOSABLE SHEET TO WRAP THIS CASE HAD ALSO BEEN TAINTED IN A BROWN COLOR. THEY DID NOT FIND ANY BREAKAGE THAT WOULD LEAD TO A PROBLEM. THEY WIPED DOWN THE CASE AND THEN USED THE INSTRUMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10144583 ↗
• MalfunctionApr 8, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: TIP OF THE HAMMER (MALLET PART) BROKE OFF AND IS NOW DISASSEMBLED FROM HANDLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT PRODUCTS: COMBINED HAMMER 700G CAN BE MOUNTED F/35. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9940433 ↗
• MalfunctionJan 28, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLIDE/FIXED HAMMER WAS DROPPED WHICH CAUSED THE HANDLE TO BRAKE. IT OCCURRED DURING SET INSPECTION. IT IS UNKNOWN IF THERE WAS PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639042 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HAMMER FELL APART IN THE WASHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617838 ↗
• MalfunctionJan 15, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT DURING AN INCOMING INSPECTION BY THE LOAN SERVICE AT LOCATION UMKIRCH IT WAS NOTED THAT THE BOLT WAS BROKEN. SINCE THIS WAS NOTED DURING AN INCOMING INSPECTION THERE ARE NO SURGERY OR PATIENT DETAILS KNOWN OR AVAILABLE. THIS REPORT IS FOR ONE (1) SLIDE/FIXED HAMMER 700 GRAMS. . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9592528 ↗
• MalfunctionJan 3, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE SLIDE/FIXED HAMMER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9548790 ↗
• MalfunctionSep 30, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT IT WAS DISCOVERED DURING AN INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135657 ↗
• InjurySep 13, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, BEFORE THE SURGERY WITH EXPERT TIBIAL NAIL, THE HOSPITAL STERILIZED THE SCREWDRIVERS AND THE COMBINED HAMMER IN QUESTION. AFTER THE STERILIZATION, AN UNKNOWN BROWN OILY LIQUID HAD SEEPED OUT AND STAINED A CASE. THE PART OF THE CASE, IN WHICH THE PHENOLIC RESIN PRODUCT WAS PLACED, WAS STAINED. THE DEVICES WERE NOT USED IN THE SURGERY BECAUSE A SURGEON USED A PLATE. THE HOSPITAL DIDN¿T CLEAN THE DEVICES BEFORE STERILIZATION. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9024727 ↗
• MalfunctionJul 26, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE SLIDE HAMMER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8833718 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT AFTER WASHING AT THE STERILE PROCESSING DEPARTMENT ON (B)(6) 2019, THE WOODEN HANDLE OF THE SLIDE/FIXED HAMMER BROKE/SPLIT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SLIDE/FIXED HAMMER 700 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8736075 ↗