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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 06/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products- hfn 130 deg 11mm x 180mm catalog#: 814511180 lot#: 944660, hfn 130 deg 11mm x 180mm catalog#: 814511180 lot#: 901380. 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. 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. Multiple mdr reports were filed for this event, please see associated reports:0001825034-2018-04612, 0001825034-2018-04614.
 
Event Description
It was reported that during a hip fracture nailing procedure, while the operating surgeon was attempting to implant the lag screw, the set screw was unable to advance. The surgeon then had to remove everything and was still unable to move the set screw. Two (2) more nails were opened and tested, and these set screws also would not advance. The surgery was later successfully completed with a new nail. No additional patient consequences were reported.
 
Event Description
It was reported that during a hip fracture nailing procedure, while the operating surgeon was attempting to implant the lag screw, the set screw was unable to advance. The surgeon then had to remove everything and was still unable to move the set screw. Two (2) more nails were opened and tested, and these set screws also would not advance. The surgery was later successfully completed with a new nail. No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. (b)(4). Complaint sample was evaluated and the reported event was confirmed. All three nails were returned and evaluated. The event of jammed set screws was confirmed. Dhr was reviewed and no discrepancies were found root cause was unable to be determined. Corrective action has been initiated to further address the event 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.
 
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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 Key7777965
MDR Text Key116931504
Report Number0001825034-2018-04611
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,distri
Type of Report Initial,Followup
Report Date 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
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 Number901300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/13/2018 Patient Sequence Number: 1
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