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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES PRODUCTS LLC COLIBRI II HANDPIECE 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 Consequences Or Impact To Patient (2199)
Event Date 01/19/2018
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Reporter's phone number was not provided. The actual device has been returned and is currently pending evaluation. Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported from (b)(6) that the small battery drive device would work and stop working repeatedly when it was switched on. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure or if a spare device was available. It was not reported if there were any 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
The date returned to manufacturer was documented as jan 26, 2018 on the initial report. It has been updated as mar 1, 2018. Device evaluation: the device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. The device was evaluated and it was determined that the motor of the small battery drive device seized, jammed, and was moving heavily. 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 will be submitted accordingly.
 
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Brand NameCOLIBRI II HANDPIECE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key7289032
MDR Text Key100684457
Report Number8030965-2018-51302
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
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 Manufacturer03/01/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2018
Is This a Reprocessed and Reused Single-Use Device? No

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