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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ULNAR BEARING ASSEMBLY TOOL PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. NEXEL ULNAR BEARING ASSEMBLY TOOL PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Failure to Advance (2524)
Patient Problem No Information (3190)
Event Date 08/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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.
 
Event Description
It was reported that the instrument clamp was found loose and was not allowing the ulnar bearings to be seated fully on the ulnar component. No additional information is available at this time.
 
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Brand NameNEXEL ULNAR BEARING ASSEMBLY TOOL
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7908039
MDR Text Key121710279
Report Number0001822565-2018-05187
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
PK123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00840108100
Device Lot Number63213944
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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