MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 8MM X 20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204398
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Tissue Breakdown (2681)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Event description updated.
Event or Problem Description
It was reported that after a knee arthroscopy aco reconstruction procedure, the patient is having an allergic reaction to the screw.The skin is breaking down and pushing pieces of the screws out.The adverse event was treated with the removal of pieces and irrigation and debridement.
Additional 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 instructions for use recommendations.2) site prep with alternate type or recommended size instruments.Per instructions 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 8MM X 20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9142282
• Report Number: 1219602-2019-01188
• Device Sequence Number: 2801355
• Product Code: MAI
• UDI-Device Identifier: 00885554036749
• UDI-Public: 00885554036749
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2021
• Device Catalogue Number: 72204398
• Device Lot Number: 50718710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 10/16/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/15/2019; 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening