MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71645027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
If was reported a partial bone fracture during surgery while inserting the lps at the distal femoral.
Additional Manufacturer Narrative
The associated trigen low profile screw and intertan nail were not returned for evaluation as they remain implanted.Our clinical investigation noted based on the limited information provided, the patient impact beyond the incomplete fracture cannot be concluded.The 2 provided photos of x-ray images support the reported complaint.It was communicated that the patient is recovering and all devices remain in-situ.No further medical assessment can be rendered at this time.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no additional complaints for this failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.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: TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7166063
• Report Number: 1020279-2018-00024
• Device Sequence Number: 1903079
• Product Code: HSB
• UDI-Device Identifier: 00885556215548
• UDI-Public: 00885556215548
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 71645027
• Device Lot Number: 17FM06146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2017
• Supplement Date Received by Manufacturer: 12/17/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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