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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 125 DEG 12MM X 165MM ROD, FIXATION

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ZIMMER BIOMET, INC. HFN 125 DEG 12MM X 165MM ROD, FIXATION Back to Search Results
Catalog Number 816712165
Device Problem Misassembled (1398)
Patient Problem No Information (3190)
Event Date 09/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 the set screw did not properly assemble with the nail. The surgeon removed the set screw and nail. A backup was used to complete the procedure.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Report source foreign - (b)(6). This product is manufactured by zimmer biomet uk and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet in warsaw, indiana manufactures a similar device in the united states. Complaint sample was evaluated and the reported event was confirmed. Upon visual inspection of the nail no visible damage could be found. The threads do not show any damage. A hex wrench was used to try to remove the screw and was unable to free it, confirming the complaint. Device history record was reviewed and no discrepancies were found. Root cause is determined to be a manufacturing and design 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 NameHFN 125 DEG 12MM X 165MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7952480
MDR Text Key123263265
Report Number0001825034-2018-09150
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PNOT CLEARED
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number816712165
Device Lot Number901680
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberRES 80755

Patient Treatment Data
Date Received: 10/10/2018 Patient Sequence Number: 1
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