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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number 110024773
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2019
Event Type  malfunction  
Manufacturer Narrative
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 during the initial procedure, when the juggerstitch was inserted into meniscus, black ring was pushed in, when pulled out to insert next part of anchor the first part was still attached.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined no serious injury was reported as a result of this malfunction.Additionally, this malfunction has not previously been reported for having caused a serious injury on a same/similar device in the past.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined no serious injury was reported as a result of this malfunction.Additionally, this malfunction has not previously been reported for having caused a serious injury on a same/similar device in the past.The initial report was forwarded in error and should be voided.
 
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Brand Name
JUGGERSTITCH CURVED IMPLANT
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9535451
MDR Text Key203499385
Report Number0001825034-2019-05812
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 distributor,health profession
Type of Report Initial,Followup
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number110024773
Device Lot Number405810
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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