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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 130 DEG 13MM X 180MM ROD, FIXATION

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ZIMMER BIOMET, INC. AFFIXUS HFN 130 DEG 13MM X 180MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Failure to Advance (2524); Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 05/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Unique identifier (udi) #: n/a. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a femoral nailing procedure, the pre loaded set screw would not advance upon insertion. Therefore, the nail was removed and another nail of same size was implanted to complete the procedure. Attempts have been made, however, no additional information has been provided at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. (b)(4). Complaint sample was evaluated and the reported event was confirmed. The nail was returned for evaluation for a stuck set screw. This was confirmed with a 5mm wrench. The nail is visually conforming to the print. Device history record was reviewed and no discrepancies relevant to the reported event were found. The root cause was determined to be related to the manufacturing process. A summary of the investigation has been sent to the complainant. 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 130 DEG 13MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7778277
MDR Text Key116941507
Report Number0001825034-2018-04710
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,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814513180
Device Lot Number970530
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-3132-2018

Patient Treatment Data
Date Received: 08/13/2018 Patient Sequence Number: 1
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