FDA Adverse Event Malfunction Summary report: N

DEMESILK

MDR report key: 6083580 · Received November 7, 2016

Report

Report Number: 3003063934-2016-00006
Event Type: Malfunction
Date Received: November 7, 2016
Date of Event: October 12, 2016
Report Date: November 1, 2016
Manufacturer: DEMETECH CORPORATION
Product Code: GAP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A COMPLETE REVIEW OF THE DHR RECORD FOR THE FINISHED PRODUCT WAS CONDUCTED. DEMESILK SIZE 2-0, PRODUCT CODE SK10X2620, LOT NUMBER EE244-16 WAS PACKAGED ON APRIL 07, 2016 AND THE REVIEW OF THE DHR DID NOT INDICATE ANY ISSUES DURING THE MANUFACTURING AND PACKAGING PROCESSES. ALL IN-PROCESS TESTS MET THEIR RESPECTIVE SPECIFICATIONS AND, IN ADDITION, THE IN-PROCESS AND FINAL PRODUCT INSPECTIONS MET THE ACCEPTANCE CRITERIA. THE REVIEW INDICATED THAT THE PRODUCT WAS MADE TO MEET STANDARD PRODUCT SPECIFICATIONS WITH NO CHANGES/MODIFICATIONS TO THE STANDARD MANUFACTURING PROCESS. A REVIEW OF THE PACKAGING AQL (ACCEPTANCE QUALITY LIMITS) INSPECTIONS THAT WERE PERFORMED DURING THE PACKAGING OF THE PRODUCT WAS CONDUCTED. DEMETECH USED AN AQL PROCEDURE BASED ON ANSI TABLES. THE QUALITY PERSONNEL DID NOT FIND ANY DEFECTS. BASED ON OUR REVIEW OF THE SAMPLES' TENSILE STRENGTH, THE DATA AT THE TIME OF PRODUCT RELEASE AND RETURNED TESTING DATA, THE TENSILE STRENGTH AND NEEDLE PULL MET ALL OF THE USP REQUIREMENTS FOR THE LOT CORRESPONDING SUTURE SIZE REQUIREMENTS. THIS INVESTIGATION CONCLUDED THAT THE QUALITY, STRENGTH, OR INTEGRITY OF THE PRODUCT WAS NOT AFFECTED.

Description of Event or Problem · 1

SUTURES BREAKS, BUT WAS NOT USED OR ADMINISTRATED TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
735420	DEMESILK	NONABSORBABLE SILK SURGICAL SUTURE	GAP	DEMETECH CORPORATION	SK10X2620	EE244-16

Patients

Seq	Age	Sex	Outcome	Treatment
1