MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 125D; NAIL, FIXATION, BONE

Model Number	71675202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Death (1802)
Date of Event	03/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through clinical trial that patient's hospitalisation was initiated/ extended and that medication therapy was administered due to pulmonary embolism.Severity was deemed as moderate and this event was marked as procedure possibly related, device non-related.Patient is recovering.
Event or Problem Description
It was reported that patient was re-addmitted with a cva and then discharged to another hospital.During a phone call the surgeon became aware that patient died during her stay at the hospital to which she was discharged.Cause of death is unknown.
Additional Manufacturer Narrative
A correction based on additional, corrected information received.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: INTERTAN 11.5MM X 18CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6713308
• Report Number: 1020279-2017-00529
• Device Sequence Number: 13666821
• Product Code: JDS
• UDI-Device Identifier: 03596010561053
• UDI-Public: 03596010561053
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/28/2017

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: 71675202
• Device Catalogue Number: 71675202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 06/15/2017; 09/18/2017; 09/18/2017; 09/18/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 09/11/2017; 09/19/2017; 11/28/2017; 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAG/COMP SCREW KIT 100/95, 71677100/UNKNOWN; LOCKING SCREW, 71643035 / UNKNOWN
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Weight: 69