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

Model Number	72200148
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the package was opened, it was found that one sterile package was missing.No patient injuries were reported.Procedure was completed with the same device.
Additional Manufacturer Narrative
Device will not be returned for evaluation.A review of the manufacturing records confirmed all components required for this product build were issued to the work order.Event description updated.
Event or Problem Description
It was reported that during the procedure, when the package was opened, it was found that one sterile package was missing.Product was implanted into the patient.No patient injuries were reported.Procedure was completed with the same device.

• Brand Name: ENDOBUTTON,CL ULTRA, 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7928434
• Report Number: 1219602-2018-01358
• Device Sequence Number: 16574685
• Product Code: MBI
• UDI-Device Identifier: 03596010597274
• UDI-Public: (01)03596010597274(17)230314(10)50720677
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 03/14/2023
• Device Model Number: 72200148
• Device Catalogue Number: 72200148
• Device Lot Number: 50720677
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1