MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 10MMX20CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71701020R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed due to ankle pain.Trigen nail implanted was found broken.No delay or back up reported.
Additional Manufacturer Narrative
The affected trigen hindfoot fusion nail was not returned for evaluation.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was manufactured in 2008.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we 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 10MMX20CM RIGHT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8066568
• Report Number: 1020279-2018-02462
• Device Sequence Number: 1746010
• Product Code: HSB
• UDI-Device Identifier: 03596010542496
• UDI-Public: 03596010542496
• Combination Product (Y/N): N
• PMA/510(K) Number: K043052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2019

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: 03/22/2018
• Device Catalogue Number: 71701020R
• Device Lot Number: 08CM16094
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 02/09/2019
• 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
• Patient Age: 48 YR