MAUDE Adverse Event Report: SYNTHES MONUMENT HAND PIECE FOR BATTERY POWERED DRIVER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESSORY & ATTACHMENT

Catalog Number 05.000.008

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter.Device is an instrument and is not implanted/explanted.A service and repair history record review was performed for the subject device.The service history of the past three years has been reviewed.The item was previously returned for service on mar 21, 2013 and jul 8, 2013, due to motor failure.The customer called in a service request for this item on (b)(6) 2016 and reported the device as inoperable-motor is slipping.The previous service conditions of motor failure are relevant to the current complained issue of the device being inoperable-motor is slipping.The manufacture date of this item is dec 15, 2016.The source of the manufacture date is the release to warehouse date.The service history evaluation is confirmed.The subject device has been received and is currently in the evaluation process.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 two hand pieces for batter powered drivers were functioning intermittently during a surgical procedure on an unknown date.It was reported that the first device's motor was slipping when the driver blade was attached and the surgeon was pressing the "forward" button.A second device was available and it was reported that it appeared to have the same issue as the first.The surgeon opted to use both devices in the "locked" position and the surgery was successfully completed with no adverse effect to the patient and no report of surgical delay.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that two hand pieces for battery powered driver (05.000.008 lots 5394644 and 004774) were not functioning as intended.In each instance the motors were running intermittently.The returned devices were sent to service and repair for investigation where the following conditions were noted: ¿ran slow¿ ¿ lot 5394644 and ¿contact plate shows sign of impact on one corner, nose piece and coupler burred and will not accept driver, runs slow in fast forward and reverse¿ ¿ lot 004774.In each instance the device was unable to be repaired and was scrapped.It was reported that two hand pieces for battery powered driver (05.000.008 lots 5394644 and 004774) were not functioning as intended.In each instance the motors were running intermittently.The service and repair technician was able to confirm the complaint condition.The instruments were forwarded to customer quality as they were not repairable.A service and repair evaluation were performed: the customer reported the motor was slipping when the driver blade was attached and the forward button was pressed.The repair technician reported the contact plate showed signs of impact on one corner, the nose piece and coupler were burred and would not accept a driver, and the motor was running slow in fast forward and reverse.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.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: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESSORY & ATTACHMENT
• 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: 5450648
• MDR Text Key: 38652805
• Report Number: 1719045-2016-10149
• Device Sequence Number: 1
• Product Code: HWE
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• 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: 004774
• Other Device ID Number: (01)10887587024585(10)004774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2006
• 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