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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 130 DEG 11MM X 180MM ROD, FIXATION

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ZIMMER BIOMET, INC. HFN 130 DEG 11MM X 180MM ROD, FIXATION Back to Search Results
Catalog Number 814511180
Device Problem Misassembled (1398)
Patient Problem No Information (3190)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.
 
Event Description
It was reported that the surgeon could not verify that the set screw was engaged in the intermedullary nail.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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 130 DEG 11MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8009413
MDR Text Key125148326
Report Number0001825034-2018-09956
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number814511180
Device Lot Number156970
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0158-2019

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