MAUDE Adverse Event Report: SYNTHES MONUMENT HAND PIECE FOR BATTERY POWERED DRIVER; SCREWDRIVERS

Catalog Number 05.000.008

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the two hand pieces for battery powered drivers were not working in the operating room.Both devices did not have power.There was no delay to the surgical procedure or patient harm this report is 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device service history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A service and repair evaluation was performed ¿ the customer reported the device was not working.The repair technician reported the motor was running slow.Motor failure is the reason for repair.The cause of the issue is unknown.The following parts were replaced: circuit board, motor, membrane switch/flex circuit, and all applicable components.This item was repaired, passed synthes final inspection and returned to the customer on 28-jul-2015.The evaluation was confirmed.A service history review was performed ¿ a service history of the past three years has been reviewed.The item was previously returned for service on 1-aug-2012 due to motor failure.The customer called in a service request for this item on 9-jul-2015 and reported that the device is inoperable-does not work.The previous service condition of motor failure is relevant to the current complained issue of the device is inoperable-does not work.The manufacture date of this item is 14-jan-2010.The source of the manufacture date is the release to warehouse date.The service history evaluation is confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information provided -there were other parts available to complete the surgery.

• Brand Name: HAND PIECE FOR BATTERY POWERED DRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4935815
• MDR Text Key: 22152153
• Report Number: 1719045-2015-10467
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.000.008
• Device Lot Number: 6304132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1