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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
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 02/15/2018
Event Type  Injury  
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 while attempting to move the set screw the set screw became stuck in the nail, and the product could not be used. The set screw was used to move the lock down on the a. R. And log screws. However, this could not be done as the set screw became stuck in the nail while moving it with the hex driver. Subsequently, the nail was removed. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Device history record was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined. 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 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 Key7478886
MDR Text Key107067673
Report Number0001825034-2018-03083
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 distributor,health profession
Type of Report Initial,Followup
Report Date 01/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814511180
Device Lot Number107580
Other Device ID Number(01) 00887868039102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/02/2018 Patient Sequence Number: 1
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