MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 18CM 130D; NAIL, FIXATION, BONE

Catalog Number	71675207
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intertan short rod broke in two while implanted in the patient.Patient suffered from a displaced fracture.Revision surgery was performed and fracture was realigned with a proximal femoral plate.
Additional Manufacturer Narrative
It was reported that the intertan short rod broke.Revision surgery was performed and fracture was realigned with a proximal femoral plate.The associated trigen intertan nail was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode for the same batch number.A clinical analysis noted the revision findings of induration and maceration from the area of the patient¿s hardware prominence was likely caused by the excessive compression during implantation as well as the fact that it occurred aprox 14 months post indicates that non-union was likely.Without the return of the actual product involved, our investigation of this report is inconclusive.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: INTERTAN 10MM X 18CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8028278
• Report Number: 1020279-2018-02314
• Device Sequence Number: 1382021
• Product Code: JDS
• UDI-Device Identifier: 03596010560865
• UDI-Public: 03596010560865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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: 04/07/2022
• Device Catalogue Number: 71675207
• Device Lot Number: 12DM04151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/04/2019
• 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