TOGGLELOC/WASHERLOC DISP KIT N/A 909846

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-04-16 for TOGGLELOC/WASHERLOC DISP KIT N/A 909846 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[105566650] (b)(4). Customer has indicated that the product will not be returned because product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location is unknown.
Patient Sequence No: 1, Text Type: N, H10


[105566651] It was reported a patient underwent a procedure to remove a piece of guide wire from the knee joint. Patient had undergone an arthroscopic procedure seven days prior. The guide wire was found via x-ray.
Patient Sequence No: 1, Text Type: D, B5


[118005307] (b)(4). This follow-up report is being submitted to relay additional information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2018-02596
MDR Report Key7433196
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2018-04-16
Date of Report2018-09-04
Date of Event2018-02-16
Date Mfgr Received2018-08-08
Device Manufacturer Date2017-12-06
Date Added to Maude2018-04-16
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameTOGGLELOC/WASHERLOC DISP KIT
Generic NameKIT, SURGICAL INSTRUMENT
Product CodeKDD
Date Received2018-04-16
Model NumberN/A
Catalog Number909846
Lot Number215190
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-04-16

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