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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CUTTER; PROSTHESIS, TRAUMA
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ZIMMER BIOMET, INC. CABLE CUTTER; PROSTHESIS, TRAUMA Back to Search Results
Model Number N/A
Device Problem Dull, Blunt (2407)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the cable cutter does not cut the cable properly.Cutting surfaces are not sharp enough.No adverse events have been reported as a result of the malfunction.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
The products were evaluated and noted to be operating without any issues.The root cause is determined to be no failure detected - device operated within specifications.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 Name
CABLE CUTTER
Type of Device
PROSTHESIS, TRAUMA
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8631365
MDR Text Key145751589
Report Number0001822565-2019-02095
Device Sequence Number1
Product Code HXZ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00392501100
Device Lot Number64218646
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Was the Report Sent to FDA? No
Date Manufacturer Received10/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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