MAUDE Adverse Event Report: I.T.S. GMBH STRAIGHT PLATE, 4.5MM, 10-HOLE

Model Number	21103-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) of the last three shipments of this plate to the distributor 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.Furthermore, we asked an experienced trauma surgeon for an additional independent opinion.In such fracture type, normally a femur nail is used, which can distribute the load best.Or a longer 4.5mm straight plate with a second neutralisation plate placed ventrally should be used to increase the oscillating area.
Event or Problem Description
It was reported that a straight plate 4.5mm 10-hole broke 1 month post-operatively.Original implant date (b)(6) 2019.A revision surgery was performed on an unknown date.

• Brand Name: STRAIGHT PLATE, 4.5MM, 10-HOLE
• Common Device Name: STRAIGHT PLATE, 4.5MM, 10-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, 8301 ; AU 8301
• MDR Report Key: 8756586
• Report Number: 3004369035-2019-00009
• Device Sequence Number: 19407287
• Product Code: HRS
• UDI-Device Identifier: 09120034304750
• UDI-Public: 09120034304750
• Combination Product (Y/N): N
• PMA/510(K) Number: K060156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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: 21103-10
• Device Catalogue Number: 21103-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR