FDA.reportPublic FDA data

MAUDE MDR 4952639

MDR report key
4952639
Report number
0001811755-2015-02772
Event key
0
Event type
3
Date of event
2015-07-02
Date received
2015-07-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. CASEY METZGER
Address
4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSTEM 5 RECIPROCATING SAWINSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENTSTRYKER INSTRUMENTS-KALAMAZOOKIJ4206000000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-300

Event Narratives#

D

Patient 1

IT WAS REPORTED DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THAT THE HANDPIECE WAS SLOW TO STOP AFTER THE TRIGGER WAS RELEASED. THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

N

Patient 1

THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING.?AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

N

Patient 1

ADDITIONAL INFORMATION: DEVICE NOT AVAILABLE FOR EVALUATION.

D

Patient 1

IT WAS REPORTED DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THAT THE HANDPIECE WAS SLOW TO STOP AFTER THE TRIGGER WAS RELEASED. THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.