MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA, 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200146
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure at the time of using the device the physician realized the package was open and empty.The problem was solved by using a back up device ( a larger endobutton size ) on the patient in order to finish the procedure.No injuries were reported.There was a delay greater than two hours.
Additional Manufacturer Narrative
Examination is not possible, as the devices have not been returned.A review of the manufacturing records confirmed all components required for this product build were issued to the work order.

• Brand Name: ENDOBUTTON CL ULTRA, 15MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7364451
• Report Number: 1219602-2018-00357
• Device Sequence Number: 952575
• Product Code: MBI
• UDI-Device Identifier: 03596010597250
• UDI-Public: (01)03596010597250(17)220124(10)50643648
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: 72200146
• Device Catalogue Number: 72200146
• Device Lot Number: 50643648
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1