NA 357.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982195944), received between Jan 23, 2017 and Nov 12, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE THE SLIDE HAMMER FOR HAMMER GUIDE WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) SLIDE HAMMER FOR HAMMER GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807265 ↗
• MalfunctionAug 11, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SLIDE SURGICAL HAMMER MALLET WAS BROKEN. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR (1) SLIDE HAMMER FOR HAMMER GUIDE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310223 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF THE SLIDE HAMMER FOR HAMMER GUIDE WAS SHATTERED INTO THREE SEPARATE PIECES AS THE SCRUB TECH DROPPED THE HAMMER ON THE GROUND. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SLIDE HAMMER FOR HAMMER GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897626 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STERILE PROCESSING DEPARTMENT (SPD) REPORTED THAT THE HANDLE OF THE SLIDE HAMMER FOR HAMMER GUIDE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) SLIDE HAMMER FOR HAMMER GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10770979 ↗
• MalfunctionMar 4, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SLAP HAMMER HANDLE BROKE DURING THE ROUTINE NAIL REMOVAL. ALSO, SCREWS ARE REMOVED. NO IMPACT TO PATIENT REPORTED. NO DELAY IN SURGERY. ALL FRAGMENTS RETRIEVED. THE SURGEON WAS ABLE TO FINISH THE REMOVAL WITH THE INSTRUMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788272 ↗
• MalfunctionSep 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THAT THE HANDLE OF THE FOLLOWING SCREWDRIVERS; (2) BALL HEX SCREWDRIVER, (2) FLEXIBLE HEXAGONAL SCREWDRIVER, SCREWDRIVER T25 L380, STARDRIVE SCREWDRIVER T25, HAMMER (2) AND SLIDE HAMMER FOR HAMMER GUIDE (2) LEAVES AN OILY DEPOSIT IN THE BOTTOM OF THE BOXES. THE STERILIZATION EQUINE HAD THE SCREWDRIVERS CLEANED ALONE AND PACK THEM INTO INDIVIDUAL BAGS. THE OILY STAINS ARE REAPPEARED IN A FEW HOURS. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7879007 ↗
• MalfunctionSep 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THAT THE HANDLE OF THE FOLLOWING SCREWDRIVERS; (2) BALL HEX SCREWDRIVER, (2) FLEXIBLE HEXAGONAL SCREWDRIVER, SCREWDRIVER T25 L380, STARDRIVE SCREWDRIVER T25, HAMMER (2) AND SLIDE HAMMER FOR HAMMER GUIDE (2) LEAVES AN OILY DEPOSIT IN THE BOTTOM OF THE BOXES. THE STERILIZATION ENGINEER HAD THE SCREWDRIVERS CLEANED ALONE AND PACK THEM INTO INDIVIDUAL BAGS. THE OILY STAINS ARE REAPPEARED IN A FEW HOURS. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS 3 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7879003 ↗
• MalfunctionJan 23, 2017Break; Break

  IT WAS REPORTED ON (B)(6) 2017 THAT AFTER THE INSTRUMENT WENT THRU THE STERILIZATION PROCESS AT THE HOSPITAL, IT WAS NOTED THAT THE HANDLE TO THE SLIDE HAMMER INSTRUMENT WAS BROKEN INTO TWO PIECES. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6271234 ↗