MAUDE Adverse Event Report: I.T.S. GMBH DISTAL FEMUR PLATE; DFL

Model Number	21302-9
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
First investigation was performed, checking the quality inspection forms as well as the material certificates and no deviation was detected.As soon we receive the device back, further investigation is performed.We have not received the device now.
Event or Problem Description
We received the information concerning a broken distal femur plate.The report of the sales rep, who discussed the issue with the surgeon, states that the bone did not consolidate in an effective manner, with a bone gap evident at one of the fracture sites, with sclerotic bone edges evident.These findings were discussed with the head surgeon and the conclusion was the diagnosis of a non-union.Two out of three fracture section healed in a proper way and one presented a non-union.

• Brand Name: DISTAL FEMUR PLATE
• Common Device Name: DFL
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• MDR Report Key: 6676245
• Report Number: 3004369035-2017-00003
• Device Sequence Number: 2059628
• Product Code: HRS
• UDI-Device Identifier: 09120034307072
• UDI-Public: 09120034307072
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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 Model Number: 21302-9
• Device Catalogue Number: 21302-9
• Device Lot Number: 20/150758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 06/29/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other