MAUDE Adverse Event Report: RAIMUND WENZLER GMBH CHROMA-LINE BLUE KERRISON RONGEUR 8IN 2MM BITE

Catalog Number NL4273-82

Device Problem Bent (1059)

Patient Problem Tissue Damage (2104)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

Microscopic evaluation revealed that no burr is present on the device.The instrument had been disassembled by unauthorized service company (safety welding broken by application of force on screw, screw slot damaged).Cutting test failed.The device showed excessive wear, the tip and footplate being damaged by unauthorized repair and/or modification, jaw bent.Review of manufacturing records showed no issues.Customer instructed to perform function check of device before reuse and not to use modified instruments.

Event Description

Per customer statement, a burr on the side and back of the tip resulted in a tear in the dura.The dura tear was repaired.The patient recovered normally and was discharged with special instructions for a dura tear.Additional information (04/27/2016): the product was not received in this condition.It was being used for a revision right l4/5 lfd when it was observed that it had a burr on the side and back of the tip.The doctor had to do a dura repair, stitching it with 6-0 prolene suture.The patient had to lay flat for 60 minutes.

• Brand Name: CHROMA-LINE BLUE KERRISON RONGEUR 8IN 2MM BITE
• Type of Device: RONGEUR
• Manufacturer (Section D): RAIMUND WENZLER GMBH; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582
• Manufacturer (Section G): RAIMUND WENZLER GMBH; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582
• Manufacturer Contact: martin wenzler ; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582 ; 4249582738
• MDR Report Key: 5700143
• MDR Text Key: 47924990
• Report Number: 9611616-2016-00001
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: NL4273-82
• Device Lot Number: 27141981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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
• Patient Outcome(s): Required Intervention