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

Catalog Number 72203841

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that the item failed during surgery and parts fell into the patient.Parts were removed from patient and no injuries were reported.

Manufacturer Narrative

Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are 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.

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

One 72203841 suturefix ultra anchor xl device returned.Complaint and attachments indicate that this single device is related to four other complaints for the same failure.(b)(4).Related devices have not yet been received at the evaluation site.The complaint stated: "it was reported that after completion of a labral repair with a suturefix ultra 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.Retrieval of this foreign body took approx.2 hours with prolonged anesthesia time and traction on patient's lower leg." the device was returned without suture or anchor.The device had previously been deployed.The outer insertion shaft is damaged.It has a pinched/flattened section as if manipulated by grasping with another instrument.There are two broken fork tines on the inner shaft of the insertion device.A bent edge is visible under magnification.Per the ifu "use of excessive force during insertion can cause failure of the suture anchor or insertion device." implantation of the suture anchor requires preparation of the insertion site.Predrilling with the appropriate smith & nephew drill bit is the preferred method of site preparation.Ensure the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair.Loss of axial alignment can encourage inadvertent bending of the device.No root cause associated with the manufacture of this device was confirmed.

• 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
• MDR Report Key: 7591126
• MDR Text Key: 111103112
• Report Number: 1219602-2018-00719
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Catalogue Number: 72203841
• Device Lot Number: 50702267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1