MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH & CO. KG CERAMO CONCEPT X PUNCH; MANUAL RONGEUR

Model Number	TEB-2X
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
In a (b)(6) hospital, a part of a manual rongeur (punch) has broken off.The broken part was retrieved from the patient.The patient was not harmed.

• Brand Name: CERAMO CONCEPT X PUNCH
• Common Device Name: MANUAL RONGEUR
• Manufacturer (Section D): FEHLING INSTRUMENTS GMBH & CO. KG; hanauer landstr. 7a; karlstein, bavaria 63791 ; GM 63791
• MDR Report Key: 8110919
• Report Number: 9615005-2018-00002
• Device Sequence Number: 234021
• Product Code: HAE
• UDI-Device Identifier: 04058749086201
• UDI-Public: (01)04058749086201(10)X16L538CK
• Combination Product (Y/N): N
• PMA/510(K) Number: K153243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: TEB-2X
• Device Catalogue Number: TEB-2X
• Device Lot Number: X16L538CK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1