MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM

Catalog Number NL4257-83T / 2430814BT

Device Problems Inadequate Service (1564); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Misassembly by Users (3133)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

The initial user information mentions a rivet falling into the patient and being retrieved immediately.This is not possible, since the instrument does not include a rivet.The second contact person corrected the original version to state that the screw had fallen into the patient and was retrieved by the surgeon.The returned device shows evidence of repeated repair work performed by unauthorized third parties.The instrument has been subject to grinding at the tip as well as on the glider and the main shaft parts.It is possible that the replacement screw involved in the incident was not secured appropriately after repair.In addition, it was not the original screw as per manufacturer's device master record and device history record.Review of manufacturing and quality control records reveals no nonconformancies.

Event Description

The surgeon was using kerrison during an operation when the screw fell out of the instrument and into the patient.The physician immediately retrieved it using a forceps.The patient was not affected and the procedure was completed as planned.

Manufacturer Narrative

This supplemental report is being submitted to correct the catalog # provided in the original report (typo).

• Brand Name: T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM
• 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 ; 4619668540
• MDR Report Key: 6108718
• MDR Text Key: 60087152
• Report Number: 8010386-2016-00009
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

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: NL4257-83T / 2430814BT
• Device Lot Number: XMEG06
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2007
• 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