MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; SCREW. CANNULATED, FAVORED ANGLE MEDIAL

Model Number	CS 3906-40-26
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer).Exemption # e2014011.
Event or Problem Description
Using x-ray evaluation, the surgeon decided to manually screw the screw a little deeper into the bone.When trying to screw the screw in further, the screw broke below the screw head.Part of the screw shaft remained in the bone.The screw type in question is a self-tapping screw which must be pre-drilled during preparation according to the surgical technique.Optionally, it is also possible to use a tap for sclerotic bone.The following findings were obtained during the initial user consultation: the hole for the screw was pre-drilled to a depth of only 12mm.The screw length is 26mm.The bone quality was described by the user as very hard due to degeneration and sclerotic attachments.

• Brand Name: NEON3
• Common Device Name: SCREW. CANNULATED, FAVORED ANGLE MEDIAL
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 8465479
• Report Number: 9612420-2019-00006
• Device Sequence Number: 2888160
• Product Code: KWP
• UDI-Device Identifier: 04052536084470
• UDI-Public: 4052536084470
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: CS 3906-40-26
• Device Catalogue Number: CS 3906-40-26
• Device Lot Number: U018204
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR