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

Model Number	72200147
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the guide wire broke during the procedure.This was not noticed until the end of the procedure.Surgery time was extended in an unsuccessful attempt to retrieve the broken piece.
Additional Manufacturer Narrative
Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was not possible due to a lot number not being provided.No further investigation is warranted at this time.(b)(4).
Additional Manufacturer Narrative
Due to no product return the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.

• 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: 6774126
• Report Number: 1219602-2017-00872
• Device Sequence Number: 1601633
• Product Code: MBI
• UDI-Device Identifier: 03596010597267
• UDI-Public: (01)03596010597267(17)200709(10)50556740
• Combination Product (Y/N): N
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2020
• Device Model Number: 72200147
• Device Catalogue Number: ED72200147
• Device Lot Number: 50556740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 09/05/2017; 06/04/2018
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 09/11/2017; 06/08/2018
• 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