MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREWDRIVER

Model Number	CS 3825-01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
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.Report is being submitted past 30 day deadline based on retrospective review conducted 6/21/2019.Original mdr (1 of 5) filed 8/29/2018.
Event or Problem Description
The surgeon was not able to successfully implant the screw; two screwdrivers broke while trying but remained intact.He decided to remove the screw and broke another screwdriver trying to do so and several pieces of metal broke off from the screwdriver but were recovered and returned along with the drivers.The surgeon was able to remove the screw using a rod and locking screw.Report 2/5.

• Brand Name: UCENTUM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 8745550
• Report Number: 9612420-2019-00028
• Device Sequence Number: 2280459
• Product Code: NKB
• UDI-Device Identifier: 04052536081202
• UDI-Public: 4052536081202
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2019
• Report Date (Section F): 08/21/2018

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: No Information
• Device Model Number: CS 3825-01
• Device Catalogue Number: CS 3825-01
• Device Lot Number: WSA14728145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 06/28/2019
• 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: 44 YR