FDA Adverse Event Malfunction Summary report: N

HIP GENERAL FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT

MDR report key: 7959965 · Received October 12, 2018

Report

Report Number: 3005180920-2018-00780
Event Type: Malfunction
Date Received: October 12, 2018
Date of Event: September 13, 2018
Report Date: October 12, 2018
Manufacturer: HPF SPA
Product Code: LXH
Product Problem: Yes
Report Source: Distributor report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER ON OCT 9, 2018: THE DRILL BITS APPEARED BROKEN IN THE MIDDLE OF THE SHAFT, WITHOUT ANY PARTICULAR VISIBLE SIGNS. THE AREA OF THE BREAKAGE IS IN THE FLUTE AREA, WHERE THE SECTION IS REDUCED DUE TO THE PRESENCE OF THE HELIX. CONSIDERING THE TYPE OF FRACTURE THE BREAKAGE SEEMS TO BE PROBABLY CAUSED BY FLEXION, BUT THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED WITH CERTAINTY. ON THE 12 OCTOBER 2018 THE MANUFACTURER HPF SENT TO MEDACTA THE DOCUMENT REVIEW: BATCH RELEASED ON DATE: (B)(4) 2015. N. OF PIECES RELEASED: (B)(4). ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. FIRST COMPLAINT RECEIVED ON THIS BATCH. THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. WE SUPPOSE THAT THE RUPTURE COULD HAVE BEEN CAUSED BY A DRILL FLEXION DURING THE USE WHICH LED TO THE DRILL BREAKAGE.

Description of Event or Problem · 1

THE DRILL BIT BROKE DURING THE ACETABULAR PREPARATION. THE SURGEON REMOVED THE CUP AND RETRIEVED THE BROKEN PIECES. THE SURGEON RE-POSITIONED THE CUP AND COMPLETED THE SURGERY SUCCESSFULLY. THE EVENT CAUSED 20 MINUTES OF DELAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
802011	HIP GENERAL FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT	SURGICAL INSTRUMENT FOR HIP SURGERIES	LXH	HPF SPA		15H9820

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other