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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 10X65 UNIFLEX TITANIUM ARTHRODESIS NAIL; ROD, FIXATION
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ZIMMER BIOMET, INC. 10X65 UNIFLEX TITANIUM ARTHRODESIS NAIL; ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.In the process of return.
 
Event Description
It was reported that during surgery, after opening the box of the product, it was noted that there were holes in the sterile packaging.No impact to patient was reported.No further information is currently available.
 
Manufacturer Narrative
The information provided on this form is a duplication of 0001825034-2018-08558.Please void this submission.
 
Event Description
No further information.
 
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Brand Name
10X65 UNIFLEX TITANIUM ARTHRODESIS NAIL
Type of Device
ROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7830308
MDR Text Key118759717
Report Number0001825034-2018-08616
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK982953
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number344065
Device Lot Number556820
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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