MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM FULL RADIUS PLATINUM SERIES; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number 72203521

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2019

Event Type  malfunction  

Event Description

It was reported that during surgery ink appeared to be rubbing off of the dyonics logo onto the tissue.No patient injuries or delay reported.The procedure was successfully completed with the same device.

Manufacturer Narrative

The reported 4.5mm full radius platinum series blade, intended for use in treatment, will not be returned for evaluation.However as photograph was supplied.Examination of the photograph showed a black substance on the patients boney surface.The photograph also exhibited scoring of the inner blade surface indicating an excessive side load was placed on the blade during use.From the information provided, ink appeared to be rubbing off of the dyonics logo.During the manufacture of all our blades no ink is used for marking purposes.An exact root cause cannot be determined with confidence without the return of the blades in question, however the black deposit described in the complaint and observed in the supplied photograph is likely a combination of silicone and shredded material.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: 4.5MM FULL RADIUS PLATINUM SERIES
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8952888
• MDR Text Key: 156306779
• Report Number: 1219602-2019-01054
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 00885554024333
• UDI-Public: 00885554024333
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2024
• Device Catalogue Number: 72203521
• Device Lot Number: 50787198
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/31/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1