TRAUMAONE SYSTEM 1.7MM X 7MM TI SELF DRILLING IMF SCREW N/A SP-3236

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-15 for TRAUMAONE SYSTEM 1.7MM X 7MM TI SELF DRILLING IMF SCREW N/A SP-3236 manufactured by Biomet Microfixation.

Event Text Entries

[175184148] Zimmer biomet complaint (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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.
Patient Sequence No: 1, Text Type: N, H10


[175184149] It was reported the screw fractured upon insertion. The fractured piece of screw remained in the patient. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2020-00065
MDR Report Key9591350
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-15
Date of Report2020-01-15
Date of Event2019-12-16
Date Mfgr Received2019-12-18
Date Added to Maude2020-01-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. JENNIFER DELANEY
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9047414400
Manufacturer G1BIOMET MICROFIXATION
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal Code32218
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameTRAUMAONE SYSTEM 1.7MM X 7MM TI SELF DRILLING IMF SCREW
Generic NameSCREW, FIXATION, INTRAOSSEOUS
Product CodeDZL
Date Received2020-01-15
Model NumberN/A
Catalog NumberSP-3236
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-15

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