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
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 8705999
• Report Number: 1421101-2019-00001
• Device Sequence Number: 2091798
• Product Code: HAE
• UDI-Device Identifier: 00190776000547
• UDI-Public: 00190776000547
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: L-0130
• Device Lot Number: 120406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention