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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. AFFIXUS 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 06/23/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product - hfn 130 deg 11mm x180mm, cat#: 814511180, lot#: 901360; hfn 130 deg 13mm x180mm, cat#: 814513180, lot#: 970530. Multiple mdr reports were filed for this event, please see all associated reports: 0001825034-2018-04697, 0001825034-2018-04698, 0001825034-2018-04699. Customer has indicated that the product will not be returned [retained by hospital] to zimmer biomet for investigation. 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 the implantation of a hip fracture nail, the set screw would not function properly and was jammed, causing the need to remove the nail from the patient. Two (2) additional nails were tested, and also had jammed set screws. The procedure was successfully completed with a fourth (4) nail, however there was a greater than thirty (30) minute delay to the procedure and the patient's femur required further reaming for a larger size nail. No additional patient consequences have been reported. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed. Device history record was reviewed and no discrepancies were found. The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. A field action was conducted in which zimmer voluntarily removed the reported product from the field due to a higher than anticipated complaint rate for the reported failure. 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 11MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7804724
MDR Text Key117855949
Report Number0001825034-2018-04697
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,health
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
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 Number944660
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZFA 2018-00344

Patient Treatment Data
Date Received: 08/22/2018 Patient Sequence Number: 1
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