MAUDE Adverse Event Report: SYNTHES GMBH BATTERY OSCILLATOR

Catalog Number 530.610

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer reported: "device gets very hot after only a few minutes".This is report 1 of 1 for complaint#(b)(4).

Manufacturer 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.During pre-repair assessment performed by a technician, functional testing was performed and revealed the motor was not functioning properly.This was attributed to normal wear.Maintenance was performed and the device was returned to the customer on (b)(4) 2013.(b)(6).Placeholder.

• Brand Name: BATTERY OSCILLATOR
• 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: 4133208
• MDR Text Key: 4944684
• Report Number: 8030965-2014-00755
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 04/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.610
• Device Lot Number: 3706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2013
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1