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

Catalog Number NL4273-82

Device Problems Inadequate Service (1564); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Device Handling Problem (3265)

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

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

The device history records, including records of acceptance testing, were reviewed for both devices and found to conform to all process and device specifications.The returned devices were visually inspected in detail and dimensional measurements were made.Both devices had been subject to extensive repair and modification by unauthorized third parties and showed evident signs of extreme wear and tear.Material had been forcefully removed from several parts of the instruments by grinding, reducing the original dimensions of the devices and compromising their cutting function as well as their load capacity.In addition to the above, the individual devices had been specifically damaged as follows: device #1, lot# 27156613: the shape of the device was changed by removal of an essential part required to ensure mechanical safety and functional effectiveness of moving parts of device.The movement of the sliding parts of the device was thus extended and caused additional damage to the tip.Device #2, lot# 27161331: the cutting edge was bent upwards.The device is intended for cutting of bony tissue.However, the tip showed damage typically caused by grasping hard objects such as wire.

Event Description

During a surgical case, two kerrison rongeurs malfunctioned and were believed to have fractured.By means of an x-ray, it was confirmed that no part of the instruments had fallen into the patient's body.The patient suffered no impact and the procedure was completed as planned.

• 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: 6315376
• MDR Text Key: 67212373
• Report Number: 9611616-2017-00001
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• 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: 27156613 / 27161331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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