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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 SPORTSMED, IMPLANTS

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ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS SPORTSMED, IMPLANTS Back to Search Results
Model Number N/A
Device Problem Fracture
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Report source: foreign - (b)(6). 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 that during the surgery, the tip of the inserter was fractured and fell into the patient's body and was removed successfully. No additional patient consequences were reported.

 
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Brand NameJGRKNT 1.0MM MINI 3-0 NDLS
Type of DeviceSPORTSMED, IMPLANTS
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 Key8674655
Report Number0001825034-2019-02422
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number912082
Device LOT Number324420
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/06/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/24/2019
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 TREATMENT DATA
Date Received: 06/06/2019 Patient Sequence Number: 1
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