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

Catalog Number 05.000.008

Device Problems Device Stops Intermittently (1599); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was reportedly no patient involvement.Additional product code: gxl.Device is an instrument and is not implanted/explanted.Service history review: 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 08january2013, 14may2013 and 31march2015 due to motor failure.The customer called in a service request for this item on 30september2015 and reported the device is in need of service, inoperable.The previous service conditions of motor failure are relevant to the current complained issue of the device is in need of service, inoperable.The manufacture date of this item is 22august2007.The source of the manufacture date is the release to warehouse date.The service history evaluation is confirmed.A service and repair evaluation was completed: the customer reported the device required service.The repair technician reported the all speed were running slow, the reverse speed was not working, and the device was loud.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.

Event Description

It was reported that several hand pieces for battery powered driver needed service.The issue did not occur during a procedure.There was no patient involvement.When the devices were evaluated by the manufacturer it was noted, that on one device the motor was running slowly and the reverse speed was not working and the device was loud; another device was locked up and would not rotate; on another one, the device was running slow and the reverse speed did not work; the contact plate was cracked on another one and the reverse speed was not working and the device was running slow.This is report 1 of 4 for (b)(4).

• 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: 5245558
• MDR Text Key: 31980715
• Report Number: 1719045-2015-10762
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• 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: 5585881
• Other Device ID Number: (01)10887587024585(10)5585881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2007
• 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