NA 03.010.058Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982067296), received between Dec 1, 2018 and Dec 4, 2023 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 THE HANDLE ON THE ADVANCED NAIL BROKE. NO FRAGMENTS GENERATED WERE INSIDE OF THE PATIENT, THE HANDLE BROKE ON THE TABLE DURING SURGERY. 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 400 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18259638 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A MALLET BROKE WHEN DROPPED ON FLOOR. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A MALLET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367776 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A HUMERAL NAIL PROCEDURE, THE SLIDE/FIXED HAMMER BROKE DURING USE. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SLIDE/FIXED HAMMER 400 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751458 ↗
• MalfunctionJul 22, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HUMERAL NAIL CASE. DURING THE PROCEDURE, THE SLIDE/FIXED HAMMER BROKE INTO MULTIPLE PIECES. NO PIECES REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THIS REPORT IS FOR A HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210990 ↗
• MalfunctionNov 4, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9273230 ↗
• InjuryOct 11, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A NAIL EXTRACTION, THE SLIDE/FIXED HAMMER HANDLE HAD A BREAKAGE AT HOSPITAL. THE UNKNOWN NAIL WAS NOT ABLE TO RETRIEVED. NO FRAGMENTS GENERATED FROM BROKEN DEVICE. THE UNKNOWN NAIL WAS UNABLE TO BE REMOVED DUE TO BONY IN GROWTH. THE SURGEON REMOVED THE LOCKING SCREWS AND DECIDED TO LEAVE THE NAIL IN THE PATIENT. NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS A 15 MINUTES SURGICAL DELAY. PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9178884 ↗
• MalfunctionJul 10, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF THE SLIDE/FIXED HAMMER SPLIT AND BROKE APART. IT WAS NOTED THAT THE DEVICE HAD BEEN DROPPED IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT.  THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8777169 ↗
• MalfunctionDec 1, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN CASE ON (B)(6) 2018, A REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM WAS USED TO HARVEST BONE GRAFT FROM A PATIENT. PRIOR TO BONE GRAFTING, A 4.5MM LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE WAS IMPLANTED. THERE WAS NO MALFUNCTION OF THE LCP CONDYLAR PLATE. PATIENT HAD A HUGE BONE VOID. THE SPACER THAT WAS IMPLANTED INITIALLY WAS REPLACED WITH BONE GRAFT HARVESTED FROM RIA. THE HUMERAL NAIL- EXPERT INSTRUMENT AND IMPLANT SET WAS OPENED TO RETRIEVE A DRILL BIT FROM THE SET. UPON INSPECTION OF THE OPENED SET, IT WAS NOTICED THAT THE HANDLE OF THE MALLET WAS BROKEN. THE MALLET WAS NOT USED OR NEEDED DURING THE CASE. THE CASE WENT WELL AND AS PLANNED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8122569 ↗