MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 17MM SUTURE WASHER STER. BOX OF ONE; WASHER, BOLT NUT

Model Number	72202992
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when tension was placed on the graft, the sutures broke.No patient injuries were reported.
Additional Manufacturer Narrative
Examination is not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: 17MM SUTURE WASHER STER. BOX OF ONE
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7146094
• Report Number: 1219602-2017-01589
• Device Sequence Number: 1066005
• Product Code: HTN
• UDI-Device Identifier: 00885554017595
• UDI-Public: (01)00885554017595(17)220317(10)50653571
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K910186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 03/17/2022
• Device Model Number: 72202992
• Device Catalogue Number: 72202992
• Device Lot Number: 50653571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 12/26/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1