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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STE MIDFOOT FUSION PLT SM TRAUMA IMPLANT

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ZIMMER BIOMET, INC. STE MIDFOOT FUSION PLT SM TRAUMA IMPLANT Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: (b)(4). 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 during the incoming inspection at the warehouse in (b)(4) a team member found debris in the sterile packaging. Attempts have been made and there is no further information at this time.
 
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Brand NameSTE MIDFOOT FUSION PLT SM
Type of DeviceTRAUMA IMPLANT
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 Key12671227
MDR Text Key277626884
Report Number0001825034-2021-02873
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00887868049729
UDI-Public(01)00887868049729(17)290107(10)801590
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number824674001
Device Lot Number801590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2019
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

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