NA 03.010.054Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982067265), received between Feb 21, 2018 and May 9, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2022. THE REVISION WAS OF HUMERAL EX NAIL AS ORIGINAL SURGERY SHOWED THAT PROXIMAL LOCKING SCREW MISSED THE NAIL. A PROXIMAL SPIRAL BLADE WAS PLACED IN TO STABILIZE. NO HARDWARE WAS REMOVED. THE ORIGINAL IMPLANTS WERE ORIGINALLY IMPLANTED APPROXIMATELY 6 MONTHS PRIOR. EXACT IMPLANT DATE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT STATUS IS UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR A INSERTION HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341044 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE INSERTION HANDLE FOR HUMERAL NAIL WAS BENT AND PIECES TO IT AND DIFFICULTY ATTACHING TO THE INSERTION HANDLE. PROCEDURE WAS SUCCESSFUL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN HUMERAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) UNK - SCREWS: LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781118 ↗
• MalfunctionFeb 21, 2018Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CASE WAS DONE ON (B)(6) 2017 AND THERE WAS AN ISSUE WITH DRILL SLEEVES JAMMING. THE SURGEON INSERTED A SHORT NAIL, SPIRAL BLADE AND SCREW IN THE PROXIMAL LOCKING HOLE. DURING THE PROCEDURE, THE DOCTOR WAS SHAKING THE JIG UP AND DOWN WHILE IT ON THE NAIL; THE DRILL SLEEVES WERE FILLED WITH TISSUE AND GOT JAMMED. THE DOCTOR WAS USING THE 3.2 DRILL SLEEVES FOR DISTAL LOCKING, HE WENT TO REMOVE THE TROCAR AND IT WAS VERY TIGHT AND DID NOT WANT TO COME OUT. THE DRILL SLEEVE AND TROCAR WAS STUCK TOGETHER. WHEN THEY WERE ABLE TO GET THE TROCAR COMBINATION DRILL SLEEVES OUT, THERE WAS A LOT OF TISSUE IN THE TIP. IT WAS CLEANED WITH PEROXIDE TO RELEASE THE TISSUE THEY WERE TAKEN OUT AND WASHED. HE THEN CONTINUED TO PUT THE SCREW IN WITHOUT CHECKING UNDER IMAGE. THE SCREWS MISSED THE NAIL AND WERE REMOVED. EVERYTHING WAS TAKEN OUT, CLEANED AND REINSERTED. ALL SCREWS WERE ABLE TO BE INSERTED CORRECTLY THEREAFTER. THE DRILL SLEEVES AND THE LOCKING JIG WERE CHECKED AFTER THE PROCEDURE AND LINED UP CORRECTLY. CONCOMITANT DEVICES: SPIRAL BLADE (PART 462.646, LOT UNKNOWN, QUANTITY 1); GUIDE WIRE (PART

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286198 ↗