MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH & CO. KG CERAMO FEHLING PUNCH; EJECTOR PUNCH

Model Number	NNR-0F
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A cervical kerrision broke during the procedure while in use.All pieces wer retrieved by the surgeon.
Additional Manufacturer Narrative
Based on the lot number, we have checked the dhr: no findings we will examine the device as soon as possible.
Event or Problem Description
A cervical kerrision broke during the procedure while in use.All pieces wer retrieved by the surgeon.
Additional Manufacturer Narrative
Based on the lot number, we have checked the dhr: no findings.The foot of the punch broke off, but the broken piece wasn't returned.Microscope photos show serious deformations of the cutting edge of the slider.Based on these findings, we assume that the breakage was caused by overloading due to cutting too hard material.(see enclosed pictures) the punch is made of hardened steel and is used for punching bone structures thinned out by milling.When used properly, it is not possible for lippage of this type to occur on the cutting edge.A material or manufacturing defect can be ruled out due to the homogeneous structure of the fracture surface.

• Brand Name: CERAMO FEHLING PUNCH
• Common Device Name: EJECTOR PUNCH
• Manufacturer (Section D): FEHLING INSTRUMENTS GMBH & CO. KG; hanauer landstr. 7a; karlstein, bavaria 63791 ; GM 63791
• Manufacturer (Section G): FEHLING INSTRUMENTS GMBH & CO. KG; hanauer landstr. 7a; karlstein, bavaria 63791 ; GM 63791
• Manufacturer Contact: esther bauer ; hanauer landstr. 7a; karlstein, bavaria 63791 ; GM 63791
• MDR Report Key: 13657803
• Report Number: 9615005-2022-80006
• Device Sequence Number: 17344677
• Product Code: HAE
• UDI-Device Identifier: 04058749063394
• UDI-Public: 04058749063394
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: NNR-0F
• Device Catalogue Number: NNR-0F
• Device Lot Number: X17J543WM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown