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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CUTTER; TRAUMA, INSTRUMENT
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ZIMMER BIOMET, INC. CABLE CUTTER; TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 00392501100
Device Problem Failure to Cut (2587)
Patient Problem No Patient Involvement (2645)
Event Date 04/26/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
 
Event Description
During the kit inspection at zimmer biomet it has been detected that the cable cutter does not cut the cable.This causes the cable to fray or to be crushed.There was no patient involvement.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed.The product was 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
TRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8627153
MDR Text Key145614939
Report Number0001822565-2019-02130
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 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00392501100
Device Lot Number64302474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Was the Report Sent to FDA? No
Date Manufacturer Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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