MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN BIOABSORBABLE BIORCI AND GTS INTERFERENCE SCREW; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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

Patient Problem Inflammation (1932)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that, after the placement of a "twinfix ultra ha" in the shoulder performed in (b)(6) 2019.The patient experienced an inflammatory reaction.Two mris scans were performed: the 1st in (b)(6) 2020 and the 2nd in (b)(6) 2021 showing a geode at level of the humoral head.The procedure was successfully completed without delay using the same faulty device.The patient current status is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.An analysis of the customer provided mri images confirmed the presence of inflammation and excess fluid around the implanted anchor.Insufficient product identification information was provided and thus the manufacturing record review and sterilization record review could not be conducted.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.The reported event was included within the potential adverse reactions.A clinical investigation concluded that the two mri scans provided confirm an inflammatory response.Possible factors include implant infection, micro-motion of the anchor, reaction to the product or a possible response to re-absorption.It was reported the procedure was successfully completed without delay using the same device, and since the patient¿s status is unknown, the impact to the patient beyond that which has been reported cannot be determined.Should any addition medical information be provided, this complaint will be re-assessed.The complaint was confirmed, and the root cause was associated with an inherent risk of the device.Factors that could have contributed to the reported event include reaction to the product or immune response to re-absorption.No containment or corrective actions are recommended at this time.

• Brand Name: UNKN BIOABSORBABLE BIORCI AND GTS INTERFERENCE SCREW
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11588480
• MDR Text Key: 242910655
• Report Number: 1219602-2021-00738
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other