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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 70 CM LENGTH ROD, FIXATION

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ZIMMER, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. The received outer pouch is only sealed on one end and doesn't appear to have ever been sealed. Root cause can be attributed to inadequate sealing of the pouch during the packaging process. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-04892, 0001822565-2017-06259, 0001822565-2017-06260. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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 tear drop guide wires sterile packaging was found unsealed during inspection.
 
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Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 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 Key6214415
MDR Text Key191618685
Report Number0001822565-2016-04892
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,Followup
Report Date 09/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model NumberN/A
Device Catalogue Number47249009800
Device Lot Number63450617
Other Device ID NumberSEE H10 NARRATIVE
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 Received08/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2016
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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