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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 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Reporter's phone number was not provided. 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 additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the small battery drive device stopped working. It was unknown if there were delays to the surgical procedure or if a spare device was available for use. There was patient involvement. There were no injuries, medical intervention or prolonged hospitalization. The exact date of the event was not reported, however it was noted that the event occurred in 2018. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
The date device returned to manufacturer was documented as june 7th, 2018 in the initial report. This has been corrected to june 11th, 2018. If additional information should become available, a supplemental medwatch report will be submitted accordingly. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the device motor seized, jammed and moved heavily. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to premature wear. 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
Manufacturer (Section G)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7626082
MDR Text Key112346398
Report Number8030965-2018-54486
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 06/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
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 Manufacturer06/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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