MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S, W/2 UB STR #1, BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203854

Device Problems Material Fragmentation (1261); Device Slipped (1584)

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

Event Date 11/15/2017

Event Type  malfunction  

Event Description

It was reported that during procedure, when knot sliding, a metal piece was found in site.It was removed from the patient.No patient injury was reported.

Manufacturer Narrative

One (b)(4) suturefix ultra suture anchor with two ultrabraid sutures received.The device is used.It is under one year old.The handle body, button, trigger and suture cover are all intact.Suture was returned separated from the device.The anchor portion is missing.Locking button was returned in the device and is pushed completely in.The deployment sliding ring is functional.This is the mechanism for fully deploying the anchor when the locking button has been freed.The device shaft is bowed.After disassembly it was confirmed that the one inner fork tine was broken off.This is the piece reported in the return.This is the result of pressure applied.Ifu states: ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.¿ proper prep is essential for successful use of this device.No root cause related to the manufacturing of this device can be established.

• Brand Name: SUTUREFIX ULTRA AHR S, W/2 UB STR #1, 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: 7061919
• MDR Text Key: 93084184
• Report Number: 1219602-2017-01485
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554030044
• UDI-Public: (01)00885554030044(17)220609(10)50668685
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: 72203854
• Device Catalogue Number: 72203854
• Device Lot Number: 50668685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2017
• 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