• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH BURR-ATTACHM XL 20° F/EPD+APD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH BURR-ATTACHM XL 20° F/EPD+APD Back to Search Results
Catalog Number 05.001.063
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer reported the device overheated.This is report 1 of 1 for (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 device overheated.An assignable root cause is undetermined.The customer replaced the device in lieu of repair.The device was returned to the customer unrepaired on (b)(4) 2012.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BURR-ATTACHM XL 20° 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 Key4128752
MDR Text Key4791775
Report Number8030965-2014-00468
Device Sequence Number1
Product Code DZI
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K043310
Number of Events Reported1
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 Received09/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05.001.063
Device Lot Number1145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2012
Is the Reporter a Health Professional? No
Date Manufacturer Received10/09/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-