MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202902

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

It was reported that during (b)(6) 2017, patient began having serious pain in the right shoulder where she had a rotator cuff surgery on (b)(6) 2016.Therefore doctor examined her and took x rays which revealed a metallic foreign body just lateral and posterior to the suture anchor.

Manufacturer Narrative

One 72202618 twinfix ultra titanium 5.5mm anchor device reported on indicating anchor failure with remnants left behind in the surgical region.Device was not returned for evaluation.Physical conclusions, full investigation and evaluation were not possible.Influences that could compromise product integrity include: site prep with alternate or without recommended instruments.Difficulty establishing and maintaining axial alignment of suture anchor with prepared insertion site.Bone quality must be adequate to allow proper placement of suture anchor.Final product met predetermined specifications upon release to distribution.

Manufacturer Narrative

Two 72202618 twinfix ultra titanium 5.5mm anchor devices reported on in relation to legal action.There were two related complaints opened for product 72202618 that relayed: ¿it was reported that during (b)(6) 2017, patient began having serious pain in the right shoulder where she had had a rotator cuff surgery on (b)(6) 2016.Therefore doctor examined her and took x rays which revealed a metallic foreign body just lateral and posterior to the suture anchor.¿ the return consisted of one single anchor body with bits of suture bound inside.This anchor is not part of 72202618 products filed on which contains a titanium anchor with four preloaded ultrabraid #2 cobraid suture and needle assemblies.The returned anchor had internal damage.There was a metal item torque fractured and embedded within the anchor core.It could not be identified.Repeat clinical reports indicated unknown metallic remnants left behind in the surgical region in proximity; just lateral and posterior to the suture anchor.Physical conclusions, full investigation and evaluation were limited due to partial product return and disparity between the anchor returned and product reported on.Attempts to retrieve a reported x-ray were unsuccessful.10600678 confirms instructions, precautionary statements and recommendations for proper use of product and includes specific step by step use instruction.¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.Bone quality must be adequate to allow proper placement of suture anchor.Needles are attached to the sutures.Use caution when deploying the needles from the handle.Do not use sharp instruments to manage or control the suture.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.¿.

Manufacturer Narrative

H10: d4: lot number, catalog number, expiration date and unique identifier added.H4: device manufacture date added.

Manufacturer Narrative

H10.H3, h6: two twinfix ultra titanium 5.5mm anchor devices reported on in relation to legal action.Two related complaints were opened for this product.The return consisted of one single anchor body with bits of suture bound inside.This anchor is not part of twinfix ultra products reported on, which contains a titanium anchor with four preloaded suture and needle assemblies.The returned anchor had internal damage.There was torque fracture of a metal item embedded within the anchor core.It could not be identified.Repeat clinical reports indicated unknown metallic remnants left behind in the surgical region in proximity; just lateral and posterior to the suture anchor.Evaluation, investigation and conclusions were limited due to inadequate physical return and disparity between the product reported on and the anchor returned.Attempts to retrieve a reported x-ray were unsuccessful.Instructions for use confirms instructions, precautionary statements and recommendations for proper use of product and includes specific step by step use instruction.¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.Bone quality must be adequate to allow proper placement of suture anchor.Needles are attached to the related sutures.Use caution when deploying the needles from the handle.Do not use sharp instruments to manage or control the suture.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.¿ complaint history review indicated no similar no allegations for the lot numbers reported.Batch review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.No root cause related to the manufacture of this device was confirmed.Further investigation is not warranted at this time.The report numbers for the mentioned devices are: 1219602-2018-01370 and 1219602-2018-01371.

• Brand Name: UNKNOWN
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7930916
• MDR Text Key: 122638220
• Report Number: 1219602-2018-01370
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K100159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Catalogue Number: 72202902
• Device Lot Number: 50563530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1