MAUDE Adverse Event Report: I.T.S. GMBH CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=12MM, RH

Model Number	37303-12
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the last three shipments of curved foot plates 21411-5 as well as the 37303-12 screw 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.On the x-ray it is visible, that the plate got bend in the area of the locking screw, that went through the hole.As stated in the technique guide the particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism.
Event or Problem Description
It was reported that a locking cancellous screw d=3.0mm was screwed through a foot plate curved 5-hole.There were no delays in surgery.This is report 2 of 2.

• Brand Name: CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=12MM, RH
• Common Device Name: CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=12MM, RH
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8230332
• Report Number: 3004369035-2016-00042
• Device Sequence Number: 215290
• Product Code: HWC
• UDI-Device Identifier: 09120047297957
• UDI-Public: 09120047297957
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Biomedical Engineer
• 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: 37303-12
• Device Catalogue Number: 37303-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2016
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention