MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 10MMX16CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71701016L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 2nd revision of the hfn to remove the 10mmx16cm left cemented version sized was performed.
Additional Manufacturer Narrative
It was reported that a second revision was performed due to infection.The associated trigen hindfoot fusion nail was not returned for evaluation.Thus the products analysis could not be performed.As device details were not made available, device history record and sterilization documentation review could not be completed.Complaint history review could not be performed with accuracy due to lack of batch information.A clinical analysis noted that the undated ct scan and x-rays were submitted for review but don¿t provide a root cause for the infection.It is unknown if the treatment plan was followed or if the patient attended rehab sessions.No lab data were submitted to substantiate an infection.The root cause of the reported infections and the resulting multiple revisions as well as the present status of the patient are unknown.Without the return of the actual product involved and no patient records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: HFN 10MMX16CM LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8725377
• Report Number: 1020279-2019-02405
• Device Sequence Number: 2522335
• Product Code: HSB
• UDI-Device Identifier: 03596010543127
• UDI-Public: 03596010543127
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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 Catalogue Number: 71701016L
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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: Required Intervention