EXTERNAL ALIGN ANKLE CLAMP 2490-49-000 249049000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for EXTERNAL ALIGN ANKLE CLAMP 2490-49-000 249049000 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[183153066] 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


[183153067] Broken and worn tibial jig lcs. Would not extend during surgery, locking mechanism was jammed, 10 minute delay whilst alternative kit sourced. Pin puller the spring has worn and a new one is required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-07590
MDR Report Key9823908
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-12
Date of Report2020-02-24
Date of Event2020-02-25
Date Mfgr Received2020-03-17
Date Added to Maude2020-03-12
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 Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 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 NameEXTERNAL ALIGN ANKLE CLAMP
Generic NameKNEE INSTRUMENT : ALIGNMENT DEVICES
Product CodeHXD
Date Received2020-03-12
Model Number2490-49-000
Catalog Number249049000
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 2020-03-12

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