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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTNER, FIXATION
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ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTNER, FIXATION Back to Search Results
Catalog Number 110024773
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
 
Event Description
It was reported that the instrument fractured during surgery.No additional information is available at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10 device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.
 
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Brand Name
JUGGERSTITCH CURVED IMPLANT
Type of Device
FASTNER, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11125005
MDR Text Key225338718
Report Number0001825034-2021-00021
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
PMA/PMN Number
K191459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number110024773
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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