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

Catalog Number 05.000.008

Device Problems Failure to Shut Off (2939); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

The service and repair department documented that the first 2 hand piece for battery powered driver (sn (b)(4)/ lot 5605586 and sn - lot 004891) were making loud noises.The third hand piece for battery powered driver (sn - lot 004373) was not turning off.The events were found after cleaning.There was no negative impact to patient and no delay during surgery.This event did not contribute to a death or injury, whether the device was misused or not.The reported instance was not an anticipated service or warranty replacement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code: gxl.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device 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

Device was used for treatment, not diagnosis.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.(b)(4).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 history was conducted.The report indicates that the past three years has been reviewed.The item was previously returned for service on 25-nov-2013 due to motor failure.The customer called in a service request for this item on 6-jan-2015 and reported the device will not turn off.The previous service condition of motor failure is relevant to the current complained issue of the device will not turn off.The manufacture date of this item is 27-sep-2011.The source of the manufacture date is the release to warehouse date.The service history evaluation is confirmed.Additional evaluation was conducted.The report indicates that the customer reported the report was running continuously.The repair technician reported the nose cone was sticking and binding.Binding is the reason for repair.The cause of the issue is unknown.The following parts were replaced: set screw, motor/gearhead barrier, housing barrier, collet spring, nose cone, cam screw, membrane switch and flex circuit, column o-ring, 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 21-jan-2015.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: 4431288
• MDR Text Key: 19304482
• Report Number: 1719045-2015-10049
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• 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: 004373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2011
• 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