• 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. SMALL BATTERY DRIVE DEVICE 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. SMALL BATTERY DRIVE DEVICE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.101
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/07/2016
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(6). Reporter¿s phone number: (b)(6). The reporter¿s complete address was not provided. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
This is report 1 of 2 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the oscillating saw attachment device worked when the bone was not being sawed; however, the device stopped working when the bone was being sawed. The device was used together with the small battery drive device. There were no delays to the surgical procedure. It was not reported if spare devices were available for use. It was reported that the devices worked pre-operatively; however, they stopped working intra- operatively. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
Correction: the manufacturer city was inadvertently documented as (b)(4). The city has been corrected from (b)(4) to (b)(4). Contact office - name/address has been updated accordingly to reflect the corrected manufacturing facility. The device manufacture date was incorrectly documented as may 6, 2013. The device manufacture date is unknown. The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the control unit supplied too little power to the engine/motor and therefore, the device did not achieve the required power. It was further determined that the motor power was too low. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to wear from normal use and servicing. 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. SMALL BATTERY DRIVE DEVICE 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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6081617
MDR Text Key59523349
Report Number8030965-2016-15482
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 10/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.101
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/07/2016 Patient Sequence Number: 1
Treatment
OSCILLATING SAW ATTACHMENT DEVICE
-
-