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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 NDL 10PK; SCREW, FIXATION, INTRAOSSEOUS

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ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDL 10PK; SCREW, FIXATION, INTRAOSSEOUS Back to Search Results
Catalog Number 912080
Device Problem Firing Problem (4011)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Concomitant medical products: 912080 jgrknt 1.0mm mini 2-0 ndl 10pk 453210, 912080 jgrknt 1.0mm mini 2-0 ndl 10pk 453210.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05581, 0001825034-2019-05582.
 
Event Description
It was reported that the three separate juggerknots misfired; that is they were unable to launch the anchor while attempting to suture in a patient's hand.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
JGRKNT 1.0MM MINI 2-0 NDL 10PK
Type of Device
SCREW, FIXATION, INTRAOSSEOUS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9476325
MDR Text Key189329540
Report Number0001825034-2019-05583
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
PMA/PMN Number
K140908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/08/2020
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 Expiration Date02/01/2024
Device Catalogue Number912080
Device Lot Number453210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received12/16/2019
Supplement Dates Manufacturer Received01/08/2020
Supplement Dates FDA Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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