MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX30CM 125D LT; NAIL, FIXATION, BONE

Catalog Number	71676549
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a fracture.The fracture started at distal screw site.Primary surgery was performed on (b)(6) 2018.(about 1 week ago) the complaint implants were not available.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the radiological imaging and complaint details provided, the revision was due to the fractured distal femoral cortex most likely secondary to the stress of the non-union of the recently reduced/im nailing of the femoral neck fracture approximately a week prior.Post-revision imaging reveals reduction with a longer im nail, cerclage cables, as well as distal through screws.Primary post-op restrictions, adherence, and/or trauma are unknown.The patient impact beyond probable pain/discomfort, the reported revision and an expected post-revision rehabilitation phase cannot be determined.No further medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: INTERTAN 1.5 11.5MMX30CM 125D LT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8188966
• Report Number: 1020279-2018-02860
• Device Sequence Number: 16672080
• Product Code: JDS
• UDI-Device Identifier: 00885556039526
• UDI-Public: 00885556039526
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 71676549
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 05/30/2019
• 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