MAUDE Adverse Event Report: S.U.A. MARTIN GMBH & CO. KG T-COAT MICRO HDL KERR RONG THIN 8IN 1MM; KERRISON RONGEUR

Catalog Number NL4252-81T / 2110814BT

Device Problems Fracture (1260); Dull, Blunt (2407); Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

The device, which was returned without the broken-off tip, was subjected to microscopic inspection.Notches were observed on the cutting edge.Paired with the general condition of the cutting edge, this suggests that the device was blunt during use.As a result, an increased amount of force would have been required for cutting, causing the tip to break.Hardness of the returned device was tested and found to conform to specifications.Review of manufacturing documents showed no nonconformities nor rework.The original material certificates were also reviewed and found to be conforming.The device conformed to specifications at the time of release.If the tip is returned, the investigation will be reopened.

Event Description

The distal tip of the kerrison rongeur broke off and fell into the patient during an acdf procedure performed under fluoroscopy.The fragment was retrieved using a forceps and the procedure was completed as planned.

• Brand Name: T-COAT MICRO HDL KERR RONG THIN 8IN 1MM
• Type of Device: KERRISON RONGEUR
• Manufacturer (Section D): S.U.A. MARTIN GMBH & CO. KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer (Section G): S.U.A. MARTIN GMBH & CO. KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer Contact: markus pauli ; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• MDR Report Key: 12712428
• MDR Text Key: 278857192
• Report Number: 8010386-2021-00001
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL4252-81T / 2110814BT
• Device Lot Number: K19XME
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention