FDA.reportPublic FDA data

MAUDE MDR 4858423

MDR report key
4858423
Report number
0001811755-2015-02249
Event key
0
Event type
3
Date of event
2015-06-01
Date received
2015-06-22
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
1TPS MICRO DRIVERDRIVER, WIRE, AND BONE DRILL, MANUALSTRYKER INSTRUMENTS-KALAMAZOODZJ5100088000Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-220

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING STERILIZATION AT THE USER FACILITY, THE TRIGGER OF THE TPS MICRO DRIVER IS STICKING. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

N

Patient 1

THE REPORTED EVENT OF STICKING TRIGGER WAS DUPLICATED. THROUGH VISUAL EVALUATION, THE TECHNICIAN OBSERVED BOTH A NON-STRYKER GASKET AND NON-STRYKER MOTOR. DISASSEMBLY OF THE DEVICE REVEALED BOTH WEAR AND CORROSION ON THE TRIGGER SHAFT. THE TRIGGER ASSEMBLY AND NON-CONFORMING PARTS WERE REPLACED, DEVICE PASSED FINAL INSPECTION, AND WAS RETURNED TO THE CUSTOMER.

D

Patient 1

IT WAS REPORTED THAT DURING STERILIZATION AT THE USER FACILITY, THE TRIGGER OF THE TPS MICRO DRIVER IS STICKING. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.