MAUDE Adverse Event Report: AVALIGN GERMAN SPECIALTY INSTRUMENTS AVALIGN MICRO KERRISON, 40 DEGREE UP, 9MM OPENING, TW 2 MM, SL 203 MM(8"), OL 270MM(10")

Catalog Number L-0130

Device Problems Break (1069); Fracture (1260)

Patient Problem Missing Value Reason (3192)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device was manufactured december 2006, sold to reporting facility network under 2 invoices: january 2007 and march 2007. Per k081651, devices are provided non-sterile and reusable. The devices are shown to withstand a minimum of 20 cycles when sterilized according to the instructions.

Event Description

Front portion of device broke off into patient's brain tissue while in use. The broken portion of the instrument was retrieved and the instrument was removed from service.

• Brand Name: AVALIGN
• Type of Device: MICRO KERRISON, 40 DEGREE UP, 9MM OPENING, TW 2 MM, SL 203 MM(8"), OL 270MM(10")
• Manufacturer (Section D): AVALIGN GERMAN SPECIALTY INSTRUMENTS; 626 cooper ct; schaumburg IL 60173
• Manufacturer (Section G): AVALIGN GERMAN SPECIALTY INSTRUMENTS; 626 cooper ct; schaumburg IL 60173
• Manufacturer Contact: jennifer staunton ; 626 cooper ct; schaumburg, IL 60173 ; 8479080292
• MDR Report Key: 8705999
• MDR Text Key: 179225607
• Report Number: 1421101-2019-00001
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: L-0130
• Device Lot Number: 120406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 06/17/2019 Patient Sequence Number: 1