MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 11MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204412
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient shows cystic formation around the tibial screw on mri at a follow up appt.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.

• Brand Name: SCREW BIOSURE REGENESORB 11MM X 30MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7838697
• Report Number: 1219602-2018-01158
• Device Sequence Number: 1189224
• Product Code: MAI
• UDI-Device Identifier: 00885554036886
• UDI-Public: (01)00885554036886(17)200505(10)50662851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2018

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: 05/05/2020
• Device Model Number: 72204412
• Device Catalogue Number: 72204412
• Device Lot Number: 50662851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 10/11/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/04/2018; 10/12/2018
• 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: Other
• Patient Age: 56 YR