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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK CANCELLOUS SCREW; PLATE, FIXATION, BONE

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ZIMMER BIOMET, INC. UNK CANCELLOUS SCREW; PLATE, FIXATION, BONE Back to Search Results
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)
Event Date 01/13/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4).G2: foreign: italy.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : device not returned.
 
Event Description
It was reported that the screw fractured during the plate removal.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This event is for the screw fracture and implant/explant dates are not needed.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.
 
Event Description
It was reported a patient experienced a tibia and fibula fracture and underwent a reduction and fixation.Subsequently, during the removal of the fibula plate and screws, one of the screws fractured and the peripheral portion remained within the bone.The procedure was completed without further complications.
 
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Brand Name
UNK CANCELLOUS SCREW
Type of Device
PLATE, FIXATION, BONE
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 Key18641694
MDR Text Key334562970
Report Number0001825034-2024-00254
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
N/A
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 03/20/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/22/2024
Initial Date FDA Received02/05/2024
Supplement Dates Manufacturer Received02/22/2024
Supplement Dates FDA Received03/20/2024
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
Patient Sequence Number1
Treatment
COMPRESSION PLATE CAT: 00494500800; UNKNOWN SCREW QTY 7
Patient Outcome(s) Other;
Patient Age44 YR
Patient SexMale
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