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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 Difficult to Advance (2920); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4): customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted. 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 surgery, the set screw would not lock completely into the lag screw. Surgeon reported that he was only able to advance the set screw a half turn and that it would not advance any further. The set screw was backed off a half turn and then re-engaged. The set screw was then reported to be locked with the lag screw correctly. No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. (b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. Corrective action has been initiated to further address the event. 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 125 DEG 11MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7656361
MDR Text Key112998326
Report Number0001825034-2018-04372
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 10/03/2018
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 Number741680
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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