MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 30MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645030
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an operation where the trigen low profile screw 5.0mm x 30mm was implanted, a ct scan was performed and the ct image showed an incomplete fracture around the lpss.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 30MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9912945
• Report Number: 1020279-2020-01113
• Device Sequence Number: 11601780
• Product Code: HSB
• UDI-Device Identifier: 00885556215593
• UDI-Public: 00885556215593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 71645030
• Device Catalogue Number: 71645030
• Device Lot Number: 19GM20517
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 11/27/2020
• 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: Hospitalization; Required Intervention