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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER; CUTTER, WIRE

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ZIMMER BIOMET, INC. CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER; CUTTER, WIRE Back to Search Results
Model Number N/A
Device Problem Dull, Blunt (2407)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that cutter does not cut the cable.No additional information available.
 
Event Description
No further information available at the time of this reporting.
 
Manufacturer Narrative
No device was returned for examination.Photography and video evidence suggests the wire was unraveling during the cutting application.In the video provided, it is noticed that the wire is unraveling as they are cutting.That wire in the video has many crimp marks so the wire used was in poor condition contributing to the unraveling that was occurring.It has been determined that to perform the cut test correctly, the cable must be new and the cutting motion has to be swift.The intended clinical application is to have the cable under tension.However, as the device was not returned a functional test could not be performed.The complaint is unable to be confirmed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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 1.8 MM MAXIMUM CABLE DIAMETER
Type of Device
CUTTER, WIRE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8583034
MDR Text Key144399577
Report Number0001822565-2019-01774
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,foreig
Type of Report Initial,Followup
Report Date 10/08/2019
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 Model NumberN/A
Device Catalogue Number00392501100
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/11/2019
Initial Date FDA Received05/06/2019
Supplement Dates Manufacturer Received10/03/2019
Supplement Dates FDA Received10/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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