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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN INSTRUMENT - TEAR DROP GUIDE WIRE 3.0 MM DIAMETER ROD, FIXATION

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ZIMMER BIOMET, INC. ZNN INSTRUMENT - TEAR DROP GUIDE WIRE 3.0 MM DIAMETER ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 09/05/2018
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint number - (b)(4). Udi #: (b)(4). Foreign - (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Expected, not yet returned.
 
Event Description
It was discovered during incoming inspection at the warehouse that one product was found to have a stain on the product. Another product was found to have the seal peeling off and also and stain on the product. There was no patient involvement.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. The stains are caused contact with racks on which the guide wires are placed during passivation. These contact points cause a small portion of the guide wire to not receive a full passivation coating, leading to an inconsistent coating appearing as a "stain" or mark. These stains are not corrosion, and do not impact the fit, form, or function of the guidewires; they are merely cosmetic. The product is conforming per zimmer biomet's criteria. 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.
 
Event Description
No additional information received.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Corrected: remove device code "packaging problem" as it is no longer applicable for this complaint.
 
Event Description
It was discovered during incoming inspection at the warehouse that two products were found to have a stain on the product. There was no patient involvement.
 
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Brand NameZNN INSTRUMENT - TEAR DROP GUIDE WIRE 3.0 MM DIAMETER
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7934839
MDR Text Key122807357
Report Number0001822565-2018-05485
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 company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249009700
Device Lot Number64091451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2018
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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