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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION

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ZIMMER, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Upon reassessment it was determined that there was no product issue. Product was evaluated and found to be within product specifications. The report was sent in error and should be voided.
 
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show the lot released with no recorded anomaly or deviation. (b)(4).
 
Event Description
It was reported that the sterile packaging on a tear drop guide wire was found to only have one seal.
 
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Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH
Type of DeviceROD, FIXATION
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 Key6215550
MDR Text Key191618801
Report Number0001822565-2016-04893
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberN/A
Device Catalogue Number47249009700
Device Lot Number63418044
Other Device ID NumberSEE H10 NARRATIVE
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 Received10/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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