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

Catalog Number 05.000.008

Device Problems Continuous Firing (1123); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Additional product code: gxl.Device is an instrument and is not implanted/explanted.The 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 service history records has been requested.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

It was reported that for one hand piece for battery powered driver the button would stick / continually run and one hand piece for battery powered driver would not stop running.The devices did not malfunction in the operating room and there was not any patient involvement.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Service/ maintenance review - eval ¿ the investigation of the complaint articles has shown that: part no: 05.000.008, serial/lot no: (b)(4), a service history of the past three years has been reviewed.The item was previously returned for service on (b)(4) 2013 due to motor failure.The customer called in a service request for this item on (b)(4) 2015 and reported that the device is inoperable-button is stuck and runs continuously.The previous service condition of motor failure is relevant to the current complained issue of the device is inoperable-button is stuck and runs continuously.The manufacture date of this item is 9-dec-2008.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.

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the buttons were stuck and the device was running continuously.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.The evaluation was 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.

• 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: 5114232
• MDR Text Key: 27146243
• Report Number: 1719045-2015-10637
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 05.000.008
• Device Lot Number: 6045837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2008
• 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