G7 SCREW 6.5MM X 40MM N/A 010001001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-27 for G7 SCREW 6.5MM X 40MM N/A 010001001 manufactured by Biomet Orthopedics.

Event Text Entries

[24202824] Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. Examination of returned device found no evidence of product non-conformance. Evaluation of device found evidence that failure mode was most likely due to misalignment when drilling or positioning the g7 screw hole. However, the root cause of the event could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10


[24202825] It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015. During the procedure, the screw would not fully seat into the acetabular cup. Competitor screws were utilized to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5


[26270747] This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2015-03836
MDR Report Key5034268
Report SourceCOMPANY REPRESENTATIVE
Date Received2015-08-27
Date of Report2015-08-27
Date of Event2015-06-03
Date Mfgr Received2015-08-27
Device Manufacturer Date2014-10-13
Date Added to Maude2015-08-27
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. MEGAN HAAS
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5743726700
Manufacturer G1BIOMET ORTHOPEDICS
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 NameG7 SCREW 6.5MM X 40MM
Generic NamePROSTHESIS, HIP
Product CodeLKD
Date Received2015-08-27
Returned To Mfg2015-07-22
Model NumberN/A
Catalog Number010001001
Lot Number3446892
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOMET ORTHOPEDICS
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-08-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.