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

Catalog Number	72200147
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8701050
• Report Number: 1219602-2019-00705
• Device Sequence Number: 2260481
• Product Code: MBI
• UDI-Device Identifier: 03596010597267
• UDI-Public: 03596010597267
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 72200147
• Device Lot Number: 50747948
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019; 07/23/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/03/2019; 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other