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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS; FASTNER, FIXATION

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ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS; FASTNER, FIXATION Back to Search Results
Catalog Number 912082
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/22/2024
Event Type  Injury  
Event Description
It was reported that a piece of the instrument fractured and was retained in the patient's body.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4).G2: foreign: japan product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
 
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, d2, g1-2, g3, g7, h1, h2, h6, h10.Visual examination of the returned product identified the tip of the inserter has fractured and not all pieces have been returned.The device was returned without sutures, the implant or the needles.Fracture analysis has been previously analyzed where bending overload was identified as the mode of failure.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.The reported event is confirmed as product was returned.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
JGRKNT 1.0MM MINI 3-0 NDLS
Type of Device
FASTNER, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18967338
MDR Text Key338437478
Report Number0001825034-2024-00823
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110879
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 06/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number912082
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/26/2024
Initial Date FDA Received03/25/2024
Supplement Dates Manufacturer Received05/14/2024
Supplement Dates FDA Received06/06/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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