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

Model Number 72203841

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/24/2018

Event Type  malfunction  

Event Description

It was reported that after completion of a labral repair with a suturefix ulta anchors.It was noted on the x-ray image a foreign body.It was a part of the anchor deployment device.The object was retrieved from the patient.Five anchors where used and it is unsure which device malfunctioned.

Manufacturer Narrative

Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were not possible without product to evaluate.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.

Manufacturer Narrative

Four 72203841 suturefix ultra anchor xl devices returned.Complaint correspondence and attachments indicate that the following complaints were all related: c-(b)(4) closed as duplicate of c-(b)(4)).All five complaints were opened for the same failure.The container held four used devices.It was labeled as c-(b)(4).That complaint was routed to evaluation in (b and closed.These four are therefore the related remaining four devices.Because the devices are not labeled individually, they were evaluated together.The devices were all returned without suture or anchor.The devices were previously deployed.The outer insertion shafts are straight and undamaged.None of the nose tubes dented or bent.The inner shaft fork tines are intact on each insertion device.There is no obvious failure accounted for on any device.They are simply tainted and missing their suture/anchors.No root cause associated with the manufacture of this device was confirmed.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Wait on all information requests.Proceed based on information provided/available for the investigation; if no further clinical information is provided, recommend closure.Approved by dr.(b)(6) and/or (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ·patient information ·surgical procedure/post-operative care review ·device labeling (including technique guides, ifus, etc.) no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's is current condition is reported as recovering as planned.Therefore no further clinical assessment is warranted based on the information provided.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's is current condition is reported as recovering as planned.Therefore no further clinical assessment is warranted based on the information provided.

• Brand Name: SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7608466
• MDR Text Key: 111301459
• Report Number: 1219602-2018-00753
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554030051
• UDI-Public: (01)00885554030051(17)220414(10)50658875
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 72203841
• Device Catalogue Number: 72203841
• Device Lot Number: 50658875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other