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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC ZNN CEPHALOMEDULLARY TARGETING GUIDE HSB

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ZIMMER INC ZNN CEPHALOMEDULLARY TARGETING GUIDE HSB Back to Search Results
Catalog Number 00249000300
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem Not Applicable (3189)
Event Date 01/08/2014
Event Type  malfunction  
Manufacturer Narrative
The targeting guide was received for evaluation. Visual exam noted thread damage at mating connection for use with impaction heads. Functional tests indicated impaction heads would not fully thread into the guide as received. Previous device history records review found no issues noted. The guide has a potential field age of approximately 1 year old. This device is used for treatment. The root cause of complaint is likely cross threading of an impaction head into the guide. It is of note that impaction heads should not require excessive force to mate the components. Alignment of impaction heads is relative to the guide and should be checked to ensure threads are not cross threaded. This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospective.
 
Event Description
It was reported the customer noted the targeting guide arrived damaged to the hospital.
 
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Brand NameZNN CEPHALOMEDULLARY TARGETING GUIDE
Type of DeviceHSB
Manufacturer (Section D)
ZIMMER INC
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46580-0708
8006136131
MDR Report Key5571584
MDR Text Key42500480
Report Number1822565-2016-01159
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 02/11/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249000300
Device Lot Number62276016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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