MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TFCC FAST FIX KIT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72203986
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a left elbow dislocation that was treated with ulnar nerve release.Patient was recovered.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.
Additional Manufacturer Narrative
H10: additional information was received by the manufacturer stating that the event reported has no relation with a smith and nephew device, therefore 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.Our initial 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: TFCC FAST FIX KIT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8340748
• Report Number: 1219602-2019-00201
• Device Sequence Number: 1915829
• Product Code: GAT
• UDI-Device Identifier: 00885554032154
• UDI-Public: 00885554032154
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

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 Model Number: 72203986
• Device Catalogue Number: 72203986
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 04/09/2019; 04/29/2020
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/10/2019; 05/11/2020
• 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 Weight: 68