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

Catalog Number 05.001.059

Device Problems Ambient Noise Problem (2877); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Device was returned for service.During service, technician found uncommon noise and heating during the procedure 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 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 made strange noise.This was attributed to faulty care and maintenance.The device was repaired and returned to the customer 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: 4036235
• MDR Text Key: 18870017
• Report Number: 8030965-2014-00903
• 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: 10/15/2012

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: 05.001.059
• Device Lot Number: 3523162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2012
• Initial Date FDA Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1