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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL YELLOW 10MM DIAMETER 34CM LENGTH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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ZIMMER BIOMET, INC. TIBIAL NAIL YELLOW 10MM DIAMETER 34CM LENGTH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient was revised due to infection and wound healing disorder.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable as sterile certs are conforming excluding the device as causing/contributing to infection.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable as sterile certs are conforming excluding the device as causing/contributing to infection.The initial report was forwarded in error and should be voided.
 
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Brand Name
TIBIAL NAIL YELLOW 10MM DIAMETER 34CM LENGTH
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key12506654
MDR Text Key272479730
Report Number0001822565-2021-02727
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 Physician
Type of Report Initial,Followup
Report Date 12/06/2021
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number47249534010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/26/2021
Initial Date FDA Received09/21/2021
Supplement Dates Manufacturer Received12/06/2021
Supplement Dates FDA Received12/07/2021
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
Patient Weight65 KG
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