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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 11MM X 180MM ROD, FIXATION

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ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 11MM X 180MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 07/31/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see all associated reports: 0001825034-2018-08697, 0001825034-2018-08698, 0001825034-2018-08699. 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.
 
Event Description
It was reported that while restoring implant tubs in the distributorship, unsterile trauma nails were discovered. The inner sterile packaging was opened inside the wrapped outer box. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
The product was evaluated through manufacturing review, however, the malfunction could not be confirmed for this device. The device was returned to zimmer biomet, however, the device was dispositioned due to an open sterile package recall and was unable to be physically evaluated. The device history records were reviewed and no discrepancies were identified. The root cause is determined to be inadequate work procedures/instructions and distribution not being integrated into the company's quality management system. 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 event information available at the time of this report.
 
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Brand NameAFFIXUS HFN 125 DEG 11MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7846669
MDR Text Key119346350
Report Number0001825034-2018-08698
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814311180
Device Lot Number178050
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-3055-2018

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