MAUDE Adverse Event Report: SYNTHES GMBH HAND PIECE FOR PIEZOELECTRIC SYSTEM

Catalog Number 05.001.401

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

Customer reported that the piezo heated up very much while working.This is report 1 of 1 for complaint #(b)(4).

Manufacturer Narrative

Additional narrative: synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.During pre-repair assessment performed by a technician, functional testing was performed and revealed the handpiece was loose and the device heated up.This was attributed to normal wear.The device was sent for external repair on (b)(4) 2013.Placeholder.

• Brand Name: HAND PIECE FOR PIEZOELECTRIC SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4033808
• MDR Text Key: 4848057
• Report Number: 8030965-2014-00817
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• 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: 40430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2012
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1