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

Catalog Number 05.000.008

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported seven hand piece for battery powered drivers were malfunctioning.Two of the devices weren't working at all, one runs constantly, one has intermittent operation, one has malfunctioning low and reverse buttons, one has a motor noise and shaft turns slowly, and one has an attachment stuck in the coupler with the coupler stuck in the locked position.The device malfunctions were discovered during testing, no patient involvement.No additional information will be made available.This report is for a device with bad motor noise, shafter turns slowly.This is report 5 of 7 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional common device name: gxl.Device is an instrument and is not implanted/explanted.A service history of the past three years has been reviewed.No service history review can be performed.The item has not previously been in for service.There is no information relevant to the current complained issue.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.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 evaluation was performed.The customer reported the motor was making a bad noise, and the shaft was turning slowly.The repair technician reported the contact plate was worn, the contacts were blackened, and the motor was grinding.Motor failure is the reason for repair.The cause of the issue is unknown.The following parts were replaced: contact plate, circuit board, motor, membrane switch/flex circuit, and all applicable components.This item was repaired, passed final inspection and returned to the customer on 5-jan-2015.The evaluation was confirmed.Jan 12, 2015 serial number was previously reported as lot number.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: 4258235
• MDR Text Key: 16541369
• Report Number: 1719045-2014-10602
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• 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: 004902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2012
• 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