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U.S. Department of Health and Human Services

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

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SYNTHES OBERDORF COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.001
Device Problems Mechanical Problem (1384); Physical Resistance (2578); Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that motor seized and was rough running.It was also noted that the device had no function.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear and strain from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported by (b)(6) that during service and evaluation, it was observed that the motor on the small battery drive device seized and was rough running.It was further observed that the device had no function.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand Name
COLIBRI
Type of Device
INSTRUMENT, 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
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5304412
MDR Text Key34333111
Report Number8030965-2015-12360
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 11/17/2015
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 Number532.001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/03/2015
Initial Date FDA Received12/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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