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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL FINISHING GUIDE; KNEE INSTRUMENT
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ZIMMER BIOMET, INC. FEMORAL FINISHING GUIDE; KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Material Twisted/Bent (2981)
Patient Problem No Information (3190)
Event Date 07/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned femoral finishing guide showed that the slot is bent and the device surface wear exhibiting signs of use.Dhr was reviewed and no discrepancies were found.It was reported that the drill was started before proper orientation was achieved.Investigation results concluded that the reported event was attributed to user error.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
It was reported during surgery, while drilling holes in the instrument it was bent.Subsequently, the procedure was completed with another device.No additional patient consequences were reported.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1825034.  .
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1825034.
 
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Brand Name
FEMORAL FINISHING GUIDE
Type of Device
KNEE INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8744198
MDR Text Key149504133
Report Number0001822565-2019-02678
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
PMA/PMN Number
K161592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42578100301
Device Lot Number63929889
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Was the Report Sent to FDA? No
Date Manufacturer Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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