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

Model Number 21302-9

Device Problem Missing Value Reason (3192)

Patient Problem Missing Value Reason (3192)

Event Date 04/05/2017

Event Type  Injury  

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 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
• Type of Device: DFL
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhöhe, styria 8301 ; AU 8301 ; 3316211214
• MDR Report Key: 6676245
• MDR Text Key: 78652908
• Report Number: 3004369035-2017-00003
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 09120034307072
• UDI-Public: 09120034307072
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21302-9
• Device Catalogue Number: 21302-9
• Device Lot Number: 20/150758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other