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

MAUDE Adverse Event Report: SYNTHES OBERDORF COLIBRI II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

  • 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 OBERDORF COLIBRI II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.101
Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/07/2016
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: (b)(4). (b)(6). The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was confirmed. An assessment was performed on the device which found that the trigger was broken off, and also noted "disassembled trigger. " the assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported from france that during an unspecified surgical procedure it was observed that the small battery drive device control switch ¿gets off during surgery. ¿ it was reported that there was no delay in the procedure due to the event. It was not reported if a spare device was available for use. There was patient involvement reported. There were no patient or user injuries reported. It was reported there was no medical intervention or prolonged hospitalization. It was reported that no part of the device fell into the surgical area. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOLIBRI II
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer (Section G)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6054560
MDR Text Key58743236
Report Number8030965-2016-15326
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-