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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 Consequences Or Impact To Patient (2199)
Event Date 06/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source, foreign ¿ events occurred in (b)(6). Product is currently not expected to return to zimmer biomet for investigation as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up medwatch will be submitted.
 
Event Description
It was reported that during the implantation of a hip fracture nail, the set-screw was stuck, and was very difficult to tighten. However, the surgeon was reportedly able to successfully advance the set screw to the correct position and complete the procedure with minimal delay. There was, however, some concern that the set screw was not fully tightened due to the issue. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. The reported event was not confirmed as no product was returned. Dhr was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined. 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.
 
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 Key7743031
MDR Text Key115904087
Report Number0001825034-2018-05165
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,foreig
Type of Report Initial,Followup,Followup
Report Date 11/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814511180
Device Lot Number970870
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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