FDA Adverse Event Malfunction Summary report: N

MYSPINE S01 DRILL BASED GUIDE

MDR report key: 8155012 · Received December 12, 2018

Report

Report Number: 3005180920-2018-00986
Event Type: Malfunction
Date Received: December 12, 2018
Date of Event: November 12, 2018
Report Date: January 17, 2019
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: PQC
UDI-DI: 07630040717571
PMA / PMN Number: K173472
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

VISUAL INSPECTION PERFORMED ON THE 19 DECEMBER 2018 BY MYSOLUTION MANAGER: AFTER THE VISUAL INSPECTION OF THE MYSPINE GUIDE, WE CONFIRM THE GUIDE HAS BEEN DESIGNED ACCORDING TO THE PROCEDURE IN FORCE. THE MODEL IS CONFORM.

Additional Manufacturer Narrative · 1

OTHER DEVICE INVOLVED: MYSPINE S01 VERTEBRA REFERENCE 7.0706 (K173472); BATCH REVIEW PERFORMED ON 12 DECEMBER 2018; LOT 00981S: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 OCTOBER 2018. EXPIRATION DATE: 2019-03-14; NO ANOMALIES FOUND RELATED TO THE PROBLEM. INVESTIGATION PERFORMED BY MYSOLUTION DEPARTMENT ON NOVEMBER 21, 2018. OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

Description of Event or Problem · 1

THE SURGEON WAS NOT ABLE TO DRILL SAFETY BECAUSE THE SLEEVE PART LENGTH OF MYSPINE S01 DRILL BASED GUIDE WAS TOO SHORT IN COMPARISON WITH OTHERS. MOREOVER IT WAS NOT ABLE TO SET ON THE SPINAL BONE STABLE. THE SURGEON DRILLED ONLY THE ENTRY POINT UNDER THE IMAGING AND PROCEEDED FREEHAND DRILLING CAUSING A CRITICAL DELAY IN THE SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
997553	MYSPINE S01 DRILL BASED GUIDE	DRILL BASED GUIDE	PQC	MEDACTA INTERNATIONAL SA		00981S	07630040717571

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other