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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 Fracture (1260)
Patient Problem No Information (3190)
Event Date 08/10/2018
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. Product not returned.
 
Event Description
It was reported that the patient underwent a revision due to implant fracture.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
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 Key8162081
MDR Text Key130266563
Report Number0001825034-2018-11323
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,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number814511180
Device Lot Number5615303
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
Treatment
ANTI-ROTATION SCREW CAT: 814501090, LOT: UNK; CORTICAL SCREW CAT: 814550034, LOT: UNK; LAG SCREW CAT 814510105, LOT: UNK; UNKNOWN ENDCAP; ANTI-ROTATION SCREW CAT: 814501090, LOT: UNK; CORTICAL SCREW CAT: 814550034, LOT: UNK; LAG SCREW CAT 814510105, LOT: UNK; UNKNOWN ENDCAP
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