MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL. KERRISON RONGEUR 8IN 4MM BITE 40 DEG. UP

Catalog Number NL4251-84T / 0140814BT

Device Problems Inadequate Service (1564); Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)

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

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device was inspected and evidence of third-party rework and repair was observed.Apparently the screw had been removed and not correctly fixated again after these unauthorized activities.Original manufacturing and quality control records were reviewed and found to be conforming.

Event Description

During a posterior lumbar fusion/fixation, the upper screw of the rongeur came loose and fell into the patient.It was retrieved immediately from the surgical field.The procedure was completed as planned and there was no harm to patient.

• Brand Name: T-COAT MICRO HDL. KERRISON RONGEUR 8IN 4MM BITE 40 DEG. UP
• 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: 6788253
• MDR Text Key: 82706915
• Report Number: 8010386-2017-00004
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL4251-84T / 0140814BT
• Device Lot Number: M5R37 / XMEV11
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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