MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG RUGGLES STEALTH MICRO KERRISON RONGEURS THIN FOOTPLATE; RONGEURS/KERRISONS/IVDS

Catalog Number RB4882/0150814BS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/14/2013

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.The device history record, including acceptance testing results, was reviewed and found to conform to specifications.No complaints with regard to similar failures have been received.Since the device was not available for testing and evaluation, neither the product problem nor its cause can be established.Device not returned to manufacturer.

Event Description

The top portion of the cutting part of the device curled up.Customer reports the surgeon was performing a spinal fusion using the device to remove bone, etc.To expose the dura.The doctor was very upset, since he states he almost tore the patient's dural sac.However, there was no patient harm.

• Brand Name: RUGGLES STEALTH MICRO KERRISON RONGEURS THIN FOOTPLATE
• Type of Device: RONGEURS/KERRISONS/IVDS
• 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: 5472562
• MDR Text Key: 39852670
• Report Number: 8010386-2016-00001
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RB4882/0150814BS
• Device Lot Number: 20121445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2012
• 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 Age: 47 YR