FDA Adverse Event Malfunction Summary report: N

SYSTEM 7 V-NOTCH SAGITTAL SAW

MDR report key: 3842697 · Received June 2, 2014

Report

Report Number: 0001811755-2014-02008
Event Type: Malfunction
Date Received: June 2, 2014
Date of Event: May 23, 2014
Report Date: May 23, 2014
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: HWE
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

Additional Manufacturer Narrative · 1

THE REPORTED OVERHEATING OF THE DEVICE WAS DUPLICATED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, IT WAS FOUND THAT THE DRIVE LINK WAS LOOSE, WHICH CAN LEAD TO THE REPORTED EVENT AND CAN BE CAUSED BY A MATERIAL FATIGUE ISSUE OR IMPACT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
320814	SYSTEM 7 V-NOTCH SAGITTAL SAW	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT	HWE	STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq	Age	Sex	Outcome	Treatment
1