HAND SURGERY OSTEO 8MM 680016000

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 2018-05-31 for HAND SURGERY OSTEO 8MM 680016000 manufactured by Depuy Orthopaedic Inc, 1818910.

Event Text Entries

[109712974] 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


[109712975] It was reported that the metal at the tip of osteotome broke on three different new osteotomes.
Patient Sequence No: 1, Text Type: D, B5


[113041827] Product complaint # pc-(b)(4). Investigation summary examination of the returned instrument confirms the reported event. Depuy 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 Number1818910-2018-61055
MDR Report Key7557967
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-05-31
Date of Report2018-05-04
Date Mfgr Received2018-06-26
Device Manufacturer Date2016-02-17
Date Added to Maude2018-05-31
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 ContactMR. CHAD GIBSON
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal465820988
Manufacturer Phone5743725905
Manufacturer G1DEPUY ORTHOPAEDIC INC, 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHAND SURGERY OSTEO 8MM
Generic NameMISCELLANEOUS JOINT INSTRUMENTS : EXTRACTION INSTRUMENTS
Product CodeHTR
Date Received2018-05-31
Returned To Mfg2018-05-29
Catalog Number680016000
Lot NumberPG257824
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDIC INC, 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-31

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