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

Catalog Number UNKNOWN

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

Patient Problem Numbness (2415)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Literature: the interposition of soft tissue between the cortical button and femoral lateral cortex significantly increases button migration but does not negatively affect knee stability and clinical outcome doi.Org/10.1016/j.Knee.2020.02.021.

Event Description

It was reported that on literature review " the interposition of soft tissue between the cortical button and femoral lateral cortex significantly increases button migration but does not negatively affect knee stability and clinical outcome", after an acl reconstruction using a biosure ha, five patients developed hypoesthesia which was treated with meniscal repair.No further information is available.

Manufacturer Narrative

Internal complaint reference: case (b)(4).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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.The complaint history review found further instances of the reported event.The instructions for use was 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.A review of risk management files found that the reported failure was documented appropriately.Attempts to obtain medical documents were unsuccessful and thus a thorough medical investigation was not performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN BIOABSORBABLE BIORCI AND GTS INTERFERENCE SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11836474
• MDR Text Key: 251133502
• Report Number: 1219602-2021-01147
• Device Sequence Number: 1
• Product Code: HWC
• 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: 06/26/2021

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1