MAUDE Adverse Event Report: I.T.S. GMBH CORTICAL SCREW, D=3.5MM

Model Number	32351-24
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We received the information, that the right most lateral screw head broke off during implantation of a symphysis plate.Due to lack of information, we have inspected the quality inspection form of the article with the appropriate lot number and no deviation was detected.
Event or Problem Description
At implanting a symphysis plate, the right most lateral screw head broke off on final tightening.

• Brand Name: CORTICAL SCREW, D=3.5MM
• Common Device Name: CORTICAL SCREW, D=3.5MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, styria 8301 ; AU 8301
• MDR Report Key: 6696334
• Report Number: 3004369035-2017-00008
• Device Sequence Number: 1972721
• Product Code: HRS
• UDI-Device Identifier: 09120034302138
• UDI-Public: 09120034302138
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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: 32351-24
• Device Lot Number: 18/169777
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 07/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other