MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 11.5MMX16CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71701116L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to an infected hfn.Implant was replaced with an antibiotic-cemented hfn as a temporal fix that will be replaced.
Additional Manufacturer Narrative
The associated trigen hindfoot fusion nail and internal hex captured screws were not returned for evaluation.Therefore the product analysis could not be performed.However, device details were provided.Thus, the review of manufacturing records was conducted which did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode.Our investigation including a review of the sterilization document indicated that products were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation 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.Without the return of the actual products involved, 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 devices or additional information be received, the complaint will be reopened.

• Brand Name: HFN 11.5MMX16CM LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8512783
• Report Number: 1020279-2019-01574
• Device Sequence Number: 1928465
• Product Code: HSB
• UDI-Device Identifier: 03596010543165
• UDI-Public: 03596010543165
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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 Expiration Date: 01/10/2026
• Device Catalogue Number: 71701116L
• Device Lot Number: 16AM07824
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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