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U.S. Department of Health and Human Services

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

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SYNTHES GMBH COLIBRI II HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.101
Device Problems Output below Specifications (3004); Noise, Audible (3273); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate. Additional narrative: device evaluation: the actual device was returned for evaluation. During repair, an evaluation was performed, and it was determined that the reported condition of the device making an unusual noise was not confirmed. Therefore, an assignable root cause was not determined. However, during evaluation, it was determined that the sticky trigger, identified during service and evaluation was confirmed. The assignable root cause was determined to be due to component failure from normal wear. Udi: (b)(4).
 
Event Description
It was reported by (b)(6) that during service and evaluation, it was determined that the moving parts of the trigger did not move smoothly on the small battery drive device and the trigger was sticky. It was further observed that the device would not run because the motor was damaged. It was further determined that the device failed pretest for check for sticky triggers, check function of device and check power with power test bench. It was noted in the service order that the device made an unusual noise and lacked torque. This event did not occur during surgery. There was no patient involvement. 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 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)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key13659563
MDR Text Key289288844
Report Number8030965-2022-01315
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2022
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 Manufacturer02/25/2022
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2021
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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