MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 9MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72204405

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Hypersensitivity/Allergic reaction (1907); Tissue Breakdown (2681)

Event Date 10/17/2018

Event Type  Injury  

Event Description

It was reported that after a procedure, the patient is having an allergic reaction to the screw.The skin is breaking down and pushing pieces of the screws out.It is unknown what was used to treat the adverse event and the outcome of the patient.

Manufacturer Narrative

One 72204398 8x20mm biosure regenesorb screw was used for treatment but was not returned for evaluation.Due to product unavailability, conclusions, investigation and evaluation were limited.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue and patient condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include: 1) use inconsistent with instruction for use recommendations.2) site prep with alternate type or recommended size instruments.Per instruction for use: read these instructions completely prior to use.Known hypersensitivity to the implant material.Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.Adverse reactions listed are: mild inflammatory reaction, foreign body reaction, infection, both deep and superficial, allergic reaction.Hazards associated with reuse of this device include, but are not limited to, patient infection and/or device malfunction.Final product met predetermined specifications upon release to distribution.

• Brand Name: SCREW BIOSURE REGENESORB 9MM X 30MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9142316
• MDR Text Key: 163118120
• Report Number: 1219602-2019-01189
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554036817
• UDI-Public: 00885554036817
• Combination Product (y/n): N
• PMA/PMN Number: K142948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2021
• Device Catalogue Number: 72204405
• Device Lot Number: 50741841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention