UNKNOWN OTHER PRODUCTS UNK SHOULDER INSTRUMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for UNKNOWN OTHER PRODUCTS UNK SHOULDER INSTRUMENT manufactured by Depuy Orthopaedics, Inc. 1818910.

Event Text Entries

[124594696] 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


[124594697] Glenoid sizer guide (44 +0) broken intraoperatively. No patient consequence.
Patient Sequence No: 1, Text Type: D, B5


[133361716] Product complaint # (b)(4). Investigation summary: no device or product details were received. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may 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 Number1818910-2018-72893
MDR Report Key7979674
Date Received2018-10-18
Date of Report2018-09-20
Date of Event2018-09-20
Date Mfgr Received2018-11-13
Date Added to Maude2018-10-18
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 ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN OTHER PRODUCTS
Generic NameOTHER PRODUCTS
Product CodeDZJ
Date Received2018-10-18
Catalog NumberUNK SHOULDER INSTRUMENT
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-18

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