MAUDE Adverse Event Report: I.T.S. GMBH DISTAL FEMUR PLATE, 5-HOLE, RIGHT

Model Number	21301-5
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the 21301-5 plate and the last three shipments of a 37592-xx were inspected and showed no deviations.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.As a result of the above and the fact that no device was returned for evaluation, this complaint is deemed unconfirmed.Device was used for treatment, not diagnosis.In addition we have filed a capa ((b)(4)) and defined a sales team training for the team of i.T.S.(b)(4) as a preventive action.
Event or Problem Description
It was reported that screws backed out of a distal femur plate 5-hole postoperatively.Original implant date (b)(6) 2016.A revision surgery was performed on (b)(6) 2016.

• Brand Name: DISTAL FEMUR PLATE, 5-HOLE, RIGHT
• Common Device Name: DISTAL FEMUR PLATE, 5-HOLE, RIGHT
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8230467
• Report Number: 3004369035-2016-00008
• Device Sequence Number: 949920
• Product Code: HRS
• UDI-Device Identifier: 09120034307034
• UDI-Public: 09120034307034
• Combination Product (Y/N): N
• PMA/510(K) Number: K093868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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 Model Number: 21301-5
• Device Catalogue Number: 21301-5
• Device Lot Number: 20/122821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention