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

Catalog Number ED0003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that several days after having a rotator cuff repair utilizing two unknown size footprint anchors and one healicoil anchor the patient presented with redness, swelling and blistering.Surgery performed (b)(6) 2015.Second procedure was performed on (b)(6) 2015 for culture and flushing of surgical site.Cultures proved negative.Picc line inserted for antibiotics; admitted into hospital.

Manufacturer Narrative

Required hospitalization to administer antibiotics and debridement.Device investigation narrative - examination is not possible, as the devices will not be returned.Based on the nature of the complaint, a review of the sterility records was conducted.The products were sterilized per specifications.All process parameters were confirmed to be within specification.No abnormalities were reported with these products during manufacture.The information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the product, one or more of its components, or its intended therapeutic action.A thorough medical assessment cannot be rendered at this time.Further investigation is not warranted at this time.Evaluation codes updated to indicate that manufacturing review was performed.(b)(4).

Manufacturer Narrative

Additional medical history and clinical information was received that did not pertain directly with this event and did not have any impact on the previously submitted reports.

• Brand Name: UNKNOWN FOOTPRINT SHOULDER ANCHOR
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5809998
• MDR Text Key: 50059234
• Report Number: 1219602-2016-00410
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ED0003
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/06/2016; 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention