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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN TEAR DROP GUIDE WIRE ROD, FIXATION, INTRAMEDULLARY

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ZIMMER BIOMET, INC. ZNN TEAR DROP GUIDE WIRE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number N/A
Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (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. 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
It was reported that a foreign substance was found in the package. This was noticed during inspection.
 
Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. The following have been updated. (b)(4). Complaint sample was evaluated and the reported event was confirmed. The examination of the returned package determined that foreign material was sealed inside the outer package. Dhr was reviewed and no discrepancies relevant to the reported event were found. The reported issue could occur if the operator didn't follow the inspection criteria, so the root cause for the reported issue determined to be manufacturing deficiency. 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.
 
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Brand NameZNN TEAR DROP GUIDE WIRE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7396556
MDR Text Key104543668
Report Number0001822565-2018-01983
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249009800
Device Lot Number63887435
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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