MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203841
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the device got broken.All broken the pieces were removed from the patient's anatomy.Back-up device was available.No patient injury reported.
Additional Manufacturer Narrative
One suturefix ultra anr xl was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The distal end of the fork has broken off.The broken portion is bent in multiple places.The break area shows signs of plastic deformation.The distal tip of the outer tube is damaged on one side.The condition of the device indicates that it was subjected to an excessive amount of force during use.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.

• Brand Name: SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8098948
• Report Number: 1219602-2018-01595
• Device Sequence Number: 11334138
• Product Code: MBI
• UDI-Device Identifier: 00885554030051
• UDI-Public: 00885554030051
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 06/13/2023
• Device Catalogue Number: 72203841
• Device Lot Number: 50741390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 11/22/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1