• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVALIGN GERMAN SPECIALTY INSTRUMENTS DIVISION MICRO KERRISON 9MM OPEN 40DEG T-COAT MICRO HANDLE KERRISON RONGEUR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AVALIGN GERMAN SPECIALTY INSTRUMENTS DIVISION MICRO KERRISON 9MM OPEN 40DEG T-COAT MICRO HANDLE KERRISON RONGEUR Back to Search Results
Model Number VM81-1273
Device Problem Component Falling (1105)
Patient Problem No Information (3190)
Event Date 10/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4); the reportable device has not been returned for an evaluation by the user facility and is not available for evaluation at this time. In addition, a device lot number is not available. A follow up was sent to the facility for return of the device and any additional information. If the reportable device should become available for examination or any additional information from the user facility, a follow up with additional information will be submitted thereafter with results from any additional investigation.
 
Event Description
Medical specialties - fell apart customer stated via email: we are having problems with the screws coming out of the kerrisons every time we use them. The screw has even fell out in the patient a couple times and the surgeon is not happy. We have been tightening the screws when we assemble them and it is not helping. We have had the service guy look at them when we he comes from sharpening but that hasn't helped either. He likes the kerrisons other than the screw issue. We had him use a different kerrison from another vendor and he doesn't like them. He likes the size and feel of these but the screw problem is becoming a patient safety issue. What do you suggest we do?? i really would hate to have to order all new kerrisons and end up with the same issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICRO KERRISON 9MM OPEN 40DEG
Type of DeviceT-COAT MICRO HANDLE KERRISON RONGEUR
Manufacturer (Section D)
AVALIGN GERMAN SPECIALTY INSTRUMENTS DIVISION
626 cooper court
schaumburg IL 60173
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6033965
MDR Text Key57870298
Report Number1423507-2016-00069
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 10/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVM81-1273
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/17/2016 Patient Sequence Number: 1
-
-