MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 11.5MMX20CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71701120R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, patient had an iatrogenic fracture in the lateral tibial shaft due to change in the surgical technique delay from (0-30) minutes reported.
Additional Manufacturer Narrative
The associated trigen hindfoot fusion nail was not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Therefore, the review of the manufacturing records and complaint history were 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.It was reported that in this procedure the surgeon employed a technique that is not to the guidelines of the surgical techniques.However, per report the surgeon was satisfied with the result.Our clinical evaluation noted that neither the requested clinical information, radiographs, operative report nor the explant were provided for inclusion in this investigation.The future impact to the patient beyond the revision cannot be determined.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; and smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: HFN 11.5MMX20CM RIGHT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8480904
• Report Number: 1020279-2019-01376
• Device Sequence Number: 1253985
• Product Code: HSB
• UDI-Device Identifier: 03596010543196
• UDI-Public: 03596010543196
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 71701120R
• Device Lot Number: 18BM12054
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 07/17/2019
• 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