SPECIALIST*2 UNIVERSAL HANDLE 96-6520 966520

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 2020-03-27 for SPECIALIST*2 UNIVERSAL HANDLE 96-6520 966520 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[185429636] (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


[185429637] It was reported that the universal handle was broken in tray. Tip was busted off the silver universal handle.
Patient Sequence No: 1, Text Type: D, B5


[187161992] Product complaint # (b)(4). Investigation summary ==> examination of the returned device confirmed the reported breakage. The damage is consistent with wear out through heavy use and servicing and the investigation did not establish a need for corrective action. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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


MAUDE Entry Details

Report Number1818910-2020-09532
MDR Report Key9891598
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-12
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2007-11-15
Date Added to Maude2020-03-27
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 NameSPECIALIST*2 UNIVERSAL HANDLE
Generic NameKNEE INSTRUMENT : HANDLES
Product CodeLXH
Date Received2020-03-27
Returned To Mfg2020-03-26
Model Number96-6520
Catalog Number966520
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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