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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDLS SCREW, FIXATION

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ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDLS SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Date 02/15/2019
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. (b)(4).

 
Event Description

It was reported that during a procedure, the juggerknot anchors would not deploy. No impact to the patient. Attempts have been made and no further information has been provided.

 
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Brand NameJGRKNT 1.0MM MINI 2-0 NDLS
Type of DeviceSCREW, FIXATION
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 Key8375568
Report Number0001825034-2019-00810
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number912076
Device LOT Number639180
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/22/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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