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

Model Number	21103-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a straight plate 4.5mm 10-hole broke after 4 months.It is not known if a hardware removal took place.The dhr shows no deviation.Device will not be available for evaluation.
Event or Problem Description
It was reported that a straight plate 4.5mm broke 4 months post-op and an orif with hardware removal was performed at 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, styria 8301 ; AU 8301
• MDR Report Key: 7308996
• Report Number: 3004369035-2018-00004
• Device Sequence Number: 1276631
• Product Code: HRS
• UDI-Device Identifier: 09120034304750
• UDI-Public: 9120034304750
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K060156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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
• Device Lot Number: 26/F43364
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/02/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR