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

Catalog Number	72204398
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery ((b)(6) 2018), patient had some sort of foreign body reaction to the screws.Patient was treated on ((b)(6) 2019) with a revision surgery to remove the anchors.Patient outcome is unknown.
Additional Manufacturer Narrative
Additional information was received from reporter stating that this event is duplicate.The adverse event was submitted under report 1219602-2019-01188.Additional information received by the customer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• 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: 9137743
• Report Number: 1219602-2019-01187
• Device Sequence Number: 2928628
• Product Code: MAI
• UDI-Device Identifier: 00885554036749
• UDI-Public: 00885554036749
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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
• 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: 10/14/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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: Required Intervention