MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 20MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72200147

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Date 02/26/2019

Event Type  Injury  

Event Description

It was reported that after a procedure, a pain, swelling and micro bloody exudation in the operation area.Is unknown if a delay happened in the procedure, and if a backup device was available.

Event Description

It was reported that after a knee procedure, patient experienced a pain, swelling and micro bloody exudation in the operation area.It is unknown if there was surgical delay or if a backup device was available to complete the procedure.Patient was reported to be in good condition.

Manufacturer Narrative

One 20mm ultra cl endobutton used for treatment, was not returned for evaluation.Due to product unavailability, physical evaluation, full investigation and conclusions were limited.There was no relationship confirmed between the reported event and the device.There is no objective evidence to suggest a direct link between the symptoms and product used during the procedure.Factors affecting device performance include: device ability, surgical ability and conformance with instructions for use which includes recommendations, precautionary statements and instructions for proper use of product.If objective evidence or relevant information becomes available to assist with evaluation the complaint will certainly be revisited.This was considered an isolated occurrence as there have been no other complaints affiliated with this lot.Product met specifications upon release to distribution.Complaint history review found no other similar reports.No clinically relevant documentation was provided for inclusion in a medical investigation; therefore, a thorough medical assessment could not be performed.It was communicated that the patient was discharged home in good status; however, "no more information can be provided.".

• Brand Name: ENDOBUTTON CL ULTRA 20MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8701050
• MDR Text Key: 148065179
• Report Number: 1219602-2019-00705
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010597267
• UDI-Public: 03596010597267
• Combination Product (y/n): N
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 72200147
• Device Lot Number: 50747948
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other