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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; FIXAION, FASTENER
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ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDLS; FIXAION, FASTENER Back to Search Results
Model Number N/A
Device Problems Failure to Fire (2610); Material Twisted/Bent (2981); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Event Description
It was reported that the anchor came out of the box and the plastic sleeve was slid halfway down the shaft.It would move upwards but was very difficult and hard to slide.It was not able to be slid downwards to its normal start position closer to the tip.Deployment was attempted but the shaft bent and the anchor was not implanted.Attempts have been made and there is no further information at this time.
 
Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the anchor came out of the box and the plastic sleeve was slid halfway down the shaft.It would move upwards but was very difficult and hard to slide.It was not able to be slid downwards to its normal start position closer to the tip.Deployment was attempted but the shaft bent and the anchor was not implanted.Attempts have been made and there is no further information at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 NDLS
Type of Device
FIXAION, FASTENER
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 Key13257706
MDR Text Key285948787
Report Number0001825034-2022-00102
Device Sequence Number1
Product Code DZL
UDI-Device Identifier00880304520820
UDI-Public(01)00880304520820(17)260426(10)549850
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K140908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/21/2022
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 Model NumberN/A
Device Catalogue Number912076
Device Lot Number549850
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/23/2021
Initial Date FDA Received01/14/2022
Supplement Dates Manufacturer Received03/18/2022
Supplement Dates FDA Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
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