MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203707

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

Patient Problems Erythema (1840); Swelling (2091)

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

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 this product during manufacture.The information provided was insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical or surgical condition or surgical procedure.A thorough medical assessment cannot be rendered at this time.Further investigation is not warranted at this time.(b)(4).

• Brand Name: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK
• 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: 5810270
• MDR Text Key: 50071943
• Report Number: 1219602-2016-00414
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151105
• 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
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 72203707
• Device Lot Number: 50497599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• 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