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  

Event Description

It was reported that the hand piece for battery powered driver was in need of service.No surgical information was available.Per the service and repair evaluation, the reverse speed will not work.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: event date: unknown.Additional product code: gxl.Device is an instrument and is not implanted/explanted.Service history review: lot 0050341: a service history of the past three years has been reviewed.The item was previously returned for service on (b)(4) 2014 due to motor failure.The customer called in a service request for this item on (b)(4) 2015 and reported the device is in need of service, inoperable.The previous service condition of motor failure is relevant to the current complained issue of the device is in need of service, inoperable.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 motor was making a buzzing sound, and the reverse speed did not work.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.

Manufacturer Narrative

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

Update: 05/05/15, per service and repair evaluation: part 05.000.008, lot 0050341 was detected from the nurse during pre-op.

• 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: 4737679
• MDR Text Key: 5703519
• Report Number: 1719045-2015-10258
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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: 0050341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2013
• 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