SP2 SIGMA INSET PATELLAR CLAMP 96-6670 966670

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-07 for SP2 SIGMA INSET PATELLAR CLAMP 96-6670 966670 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[175222574] Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[175222575] It was reported that the clamp on the end of the handle doesn? T click in. Therefore it falls out. All pieces were removed from the field. Lot number was unknown or time was no extended.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-00845
MDR Report Key9558081
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-07
Date of Report2019-12-17
Date of Event2019-12-17
Date Mfgr Received2020-02-05
Date Added to Maude2020-01-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER PA 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSP2 SIGMA INSET PATELLAR CLAMP
Generic NameKNEE INSTRUMENT : PATELLA HANDLE/CLAMPS
Product CodeHXD
Date Received2020-01-07
Model Number96-6670
Catalog Number966670
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-07

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