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

Model Number	ED72204412
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	08/30/2017
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.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include: ·patient information ·surgical procedure/post-operative care review ·device labeling (including technique guides, ifus, etc.) based the information provided it was reported the doctor believes the open architecture of the screw allowed fluid from the joint to run down into the tibial tunnel.In addition, the doctor reported, " i don't believe the patient has any pain at this point." since this screw is bio-compatible and no revision surgery has been scheduled.Its unknown how long after the procedure the mri was performed.No further clinical/medical assessment is warranted at this time.Approved by (b)(6) md on (b)(6) 2018.Based the information provided it was reported the doctor believes the open architecture of the screw allowed fluid from the joint to run down into the tibial tunnel.In addition, the doctor reported, " i don't believe the patient has any pain at this point." since this screw is bio-compatible and no revision surgery has been scheduled.Its unknown how long after the procedure the mri was performed.No further clinical/medical assessment is warranted at this time.Approved by (b)(6) md on (b)(6) 2018.

• 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: 7838705
• Report Number: 1219602-2018-01160
• Device Sequence Number: 1291000
• Product Code: MAI
• UDI-Device Identifier: 00885554036886
• UDI-Public: (01)00885554036886(17)200505(10)50662852
• 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): 08/31/2018

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: ED72204412
• Device Catalogue Number: ED72204412
• Device Lot Number: 50662852
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 09/27/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/04/2018; 10/01/2018
• 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: 57 YR