MAUDE Adverse Event Report: SYNTHES GMBH CRANIOTOME-ATTACHM F/EPD+APD

Catalog Number 05.001.059

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer reported rotation very close to the minimum required and heating of the cable with less than 3 minutes of equipment's use, even wearing glove, it is impossible to hold the handpiece.This is report 1 of 2 for complaint #(b)(4) for the craniotome attachment.

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.(b)(6).During pre-repair assessment performed by a technician, functional testing was performed and revealed the device had no defects or failures.Maintenance was performed and the device was returned to the customer unrepaired on (b)(4) 2012.Placeholder.

• Brand Name: CRANIOTOME-ATTACHM F/EPD+APD
• 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: 4079833
• MDR Text Key: 4825588
• Report Number: 8030965-2014-00930
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K043310
• 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: 10/09/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.059
• Device Lot Number: 10640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1