MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDBUTN CL BTB STERILE 25MM BOX OF 1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	7210081
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reprter's zip code: (b)(6).
Event or Problem Description
It was reported that when the box was opened, there was no implant inside and no sticker label either.The only thing inside the box was the product brochure.The surgeon decides to use another company's products instead.No patient injuries were reported.
Additional Manufacturer Narrative
Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: ENDBUTN CL BTB STERILE 25MM BOX OF 1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6851239
• Report Number: 1219602-2017-01080
• Device Sequence Number: 18956469
• Product Code: GAT
• UDI-Device Identifier: 03596010496973
• UDI-Public: (01)03596010496973(17)210516(10)50601708
• 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: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: 05/16/2021
• Device Model Number: 7210081
• Device Catalogue Number: 7210081
• Device Lot Number: 50601708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1