MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; T-HANDLE

Model Number CS 7140

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 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 5/5.

• Brand Name: UCENTUM
• Type of Device: T-HANDLE
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; na; ulm, 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchbrunnenweg 12; na; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 8745549
• MDR Text Key: 149551804
• Report Number: 9612420-2019-00031
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536078271
• UDI-Public: 4052536078271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2018,06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CS 7140
• Device Catalogue Number: CS 7140
• Device Lot Number: BEA1670902313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2018
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR