MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; LONGARM SCREW, PRE-FIXATION, 7.5MM, LENGTH 50MM

Model Number	CS 3805-075-050
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/01/2017
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
Surgeon was inserting screw using a powered screwdriver and screwed it too far into the bone.The screw head broke off from the tulip and the broken pieces were removed and replaced.This caused a delay in surgery and the patient reported post-operative pain and discomfort that the surgeon attributed to this event.

• Brand Name: UCENTUM
• Common Device Name: LONGARM SCREW, PRE-FIXATION, 7.5MM, LENGTH 50MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6905882
• Report Number: 9612420-2017-00024
• Device Sequence Number: 19160780
• Product Code: NKB
• UDI-Device Identifier: 04052536079926
• UDI-Public: 4052536079926
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: No Information
• Device Model Number: CS 3805-075-050
• Device Catalogue Number: CS 3805-075-050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 09/29/2017
• 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