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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL YELLOW 10MM DIAMETER 32CM LENGTH ROD, FIXATION

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ZIMMER BIOMET, INC. TIBIAL NAIL YELLOW 10MM DIAMETER 32CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Impaired Healing (2378); Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient experienced pseudoarthrosis on unknown date. Patient was treated with osteosynthesis using additive anteromedial plate for delayed fracture healing of the tibial shaft. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameTIBIAL NAIL YELLOW 10MM DIAMETER 32CM LENGTH
Type of DeviceROD, FIXATION
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 Key12446565
MDR Text Key270528351
Report Number0001822565-2021-02564
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number47249532010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/09/2021 Patient Sequence Number: 1
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