MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE

Catalog Number PDP340H

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2019

Event Type  Malfunction  

Manufacturer Narrative

Product complaint # (b)(4). A manufacturing record evaluation was performed for the finished device mck785 number, and no non-conformance's were identified. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a tendon of achilles repair surgery in 2019 and the suture was used. During the suturing, the suture fractionated without making a relevant force and it broke. Another like suture was used to complete the procedure successfully. There were no patient consequences reported.

• Brand Name: PDS+ VIO 27IN 0 S/A CT-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8849206
• MDR Text Key: 152916084
• Report Number: 2210968-2019-84973
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (Y/N): N
• Reporter Country Code: CO
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/05/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/31/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 02/29/2020
• Device Catalogue Number: PDP340H
• Device LOT Number: MCK785
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/26/2018
• Is The Device Single Use?: Yes

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial