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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 11MM X 180MM ROD, FIXATION

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ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG 11MM X 180MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Failure to Advance (2524); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has not yet indicated if the product will 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.
 
Event Description
It is reported that during a hip fracture nailing procedure, the set screw could not be advanced or reversed from its original position. Once it was determined that the nail was malfunctioning, the surgeon requested that another product be opened to complete the procedure. No patient consequences were reported as a result of the malfunction. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Udi -(b)(4). Upon evaluation of the returned product, it is confirmed the set screw is stuck in the nail. No damage was noted on the threads. Dhr was reviewed and no discrepancies were found. A previous investigation determined the root cause to be a manufacturing issue. 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 additional information received.
 
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Brand NameAFFIXUS HFN 125 DEG 11MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7655891
MDR Text Key112996784
Report Number0001825034-2018-04371
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 12/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814311180
Device Lot Number219770
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-3055-2018

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