MAUDE Adverse Event Report: DEMETECH, INC. DEMEGUY; SURGICAL SUTURE

Model Number DT-636-1(CC223019F4P)

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

A complete review of the dhr record for the finished product was conducted.Demegut size 3-0, product code cc123019f4p, lot number ww152-15 was packaged on february 11, 2016 and product code dt-636-1 (cc223019f4p), lot number ww241-15 and the review of the dhrs 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 retained testing data, the tensile strength and needle pull met all of the usp requirements for the lots corresponding suture size requirements.Demetech did not receive any samples for lot number ww152-15 and ww241-15.This investigation concluded that the quality, strength, or integrity of the product was not affected.

Event Description

On (b)(6) 2016, (b)(6) notified demetech corp that two separate doctors complaining about the same two issues.The first was the threads were breaking and the second was the needle was coming off the threads for the following lot numbers ww152-16 and ww241-15, product codes cc123019f4p & dt-636-1(cc223019f4p).

• Brand Name: DEMEGUY
• Type of Device: SURGICAL SUTURE
• Manufacturer (Section D): DEMETECH, INC.; 14175 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): DEMETECH, INC.; 14175 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: linda hernandez ; 14175 nw 60 avenue; miami lakes, FL 33014 ; 3058241048
• MDR Report Key: 6083534
• MDR Text Key: 59566482
• Report Number: 3003063934-2016-00002
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• PMA/PMN Number: K072930
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Model Number: DT-636-1(CC223019F4P)
• Device Lot Number: WW241-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR