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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5MM HEX 1 PC DRIVER; TRAUMA, INSTRUMENT
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ZIMMER BIOMET, INC. 5MM HEX 1 PC DRIVER; TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 00114704950
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 that the product was returned fractured.There was no reported patient involvement.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Upon receipt of additional information it has been determined that the reported device does not fall under zimmer biomet design control.The supplier has been informed of this complaint and will initiate their own investigation.
 
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Brand Name
5MM HEX 1 PC DRIVER
Type of Device
TRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8815997
MDR Text Key152048997
Report Number0001822565-2019-03133
Device Sequence Number1
Product Code HWR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00114704950
Device Lot Number50543200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/25/2019
Initial Date FDA Received07/23/2019
Supplement Dates Manufacturer Received09/20/2019
Supplement Dates FDA Received09/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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