MAUDE Adverse Event Report: SYNTHES OBERDORF HAND PIECE FOR PIEZOELECTRIC SYSTEM; DRILL, BONE, POWERED

Catalog Number 05.001.401

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that three (3) device failed inspection.All of the devices only worked intermittently.There was no surgical or patient involvement.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the service history records has been requested.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.A service and repair evaluation was performed for the subject device.The customer reported the device was only working intermittently.The item passed testing and worked within normal parameters.The complained issue was not able to be reproduced.The cause of the complained issue is unknown.The device was sent to the vendor for further testing on 7-jul-2015.This item passed synthes final inspection and was returned to the customer on 11-aug-2015.The evaluation was unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Service history review: service history review: lot 203965.001: a service history of the past three years has been reviewed.The item was previously returned for service on (b)(4) 2012, (b)(4) 2013 and the device passed testing.The customer called in a service request for this item on (b)(4) 2015 and device failed inspection-works intermittently.The previous service conditions of device passed testing are not relevant to the current complained issue of device failed inspection-works intermittently.The manufacture date of this item is 14january2011.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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 PIEZOELECTRIC SYSTEM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4887379
• MDR Text Key: 16188435
• Report Number: 8030965-2015-11160
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.401
• Device Lot Number: 203965.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2011
• 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