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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 11 MM FIXATION, BONE

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ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 11 MM FIXATION, BONE Back to Search Results
Catalog Number 47249530011
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has been returned. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified. No patient or surgical involvement. No further information available at this time.
 
Manufacturer Narrative
Reported packaging damage event was confirmed via visual examination. It was identified the complete packaging was missing/not returned. Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified. Root cause is unknown. 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 further information available at the time of this reporting.
 
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Brand NameTIBIAL NAIL - YELLOW 11 MM
Type of DeviceFIXATION, BONE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8840808
MDR Text Key152636794
Report Number0001822565-2019-03013
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K082770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47249530011
Device Lot Number63711834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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