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

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL CONNECTING KNOB TRAUMA INSTRUMENT

  • 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
 

ZIMMER, INC. ZIMMER NATURAL NAIL CONNECTING KNOB TRAUMA INSTRUMENT Back to Search Results
Catalog Number 00249000014
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/03/2017
Event Type  Injury  
Manufacturer Narrative
The device history records could not be reviewed as the lot number was not provided. No product was returned for review as it was scrapped by the hospital. This device was used for treatment. As the lot number is not known, no complaint history search for the lot number could be completed. The most likely root cause of the instrument cannot be determined.
 
Event Description
It is reported that during a trauma fixation procedure, the blue connecting knob broke upon impaction and pieces fell in the patient. All pieces were recovered and another device was not required to complete the surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZIMMER NATURAL NAIL CONNECTING KNOB
Type of DeviceTRAUMA INSTRUMENT
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6354810
MDR Text Key68186814
Report Number0001822565-2017-01159
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK083497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 02/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249000014
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 Received01/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/23/2017 Patient Sequence Number: 1
-
-