UNKNOWN MCP INSTRUMENT UNK_SEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-17 for UNKNOWN MCP INSTRUMENT UNK_SEL manufactured by Stryker Gmbh.

Event Text Entries

[120829192] Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[120829193] Customer reported that during surgery, the mcp instrument was available for use instead of the pip instrument. The surgeon only realized with the patient asleep on the table and with the hand opened. The surgeon then proceeded to try his best to implant 2 x pip implants however this was unsuccessful and the patient will need relisted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2018-00605
MDR Report Key7883136
Date Received2018-09-17
Date of Report2018-11-16
Date of Event2018-08-20
Date Mfgr Received2018-10-25
Date Added to Maude2018-09-17
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. ANNA JUSINSKI
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN MCP INSTRUMENT
Generic NameIMPLANT
Product CodeKYJ
Date Received2018-09-17
Catalog NumberUNK_SEL
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-09-17

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