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	05/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this is now the 3rd revision of the hfn to remove the above cemented version sized.Patient was still infected.
Additional Manufacturer Narrative
The associated trigen hindfoot fusion nail was not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.The manufacturing records, sterilization documentation and complaint history review was conducted.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Product was sterilized according to sterilization release documentation from quality control.Our investigation included a clinical evaluation which noted that based on the imaging, operative note, and antibiotic therapy per id, a chronic infection (osteomyelitis?) was most likely the contributing factor to the multi-stage revision, although no organism, source, pathology or patient medical history was provided.The patient impact beyond the reported revisions, antibiotic therapy and probable pain cannot be determined.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should 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: 8704289
• Report Number: 1020279-2019-02293
• Device Sequence Number: 1822441
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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
• Device Lot Number: 12FM00829A
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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: Hospitalization; Required Intervention