DLC DEPTH GAUGE 227436000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-19 for DLC DEPTH GAUGE 227436000 manufactured by Depuy Orthopaedics Inc Us 1818910.

Event Text Entries

[120974227] Product complaint # (b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. 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. Depuy orthopaedics, inc. (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


[120974228] Spring on depth gauge defective. No delay. No patient harm. Patient consequence? :no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2018-69767
MDR Report Key7889444
Date Received2018-09-19
Date of Report2018-08-27
Date of Event2018-08-06
Date Mfgr Received2018-08-27
Device Manufacturer Date2015-10-28
Date Added to Maude2018-09-19
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 ContactCHAD GIBSON
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone5743725905
Manufacturer G1DEPUY ORTHOPAEDICS INC US 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDLC DEPTH GAUGE
Generic NameHIP INSTRUMENTS : DRILL GUIDES
Product CodeHJT
Date Received2018-09-19
Returned To Mfg2018-08-27
Catalog Number227436000
Lot NumberAG2018471
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-19

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