MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72200148

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

It was reported that the endobutton's thick rope started to fluff and could not longer be used.It is unknown whether the event happened during surgery and if there was a patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: ENDOBUTTON CL ULTRA 25MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10589622
• MDR Text Key: 208630581
• Report Number: 1219602-2020-01477
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010597274
• UDI-Public: 03596010597274
• Combination Product (y/n): N
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 72200148
• Device Catalogue Number: 72200148
• Device Lot Number: 2032613
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1