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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 Noise, Audible (3273); Complete Loss of Power (4015); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
It was reported from (b)(6) that the small battery drive device was generating heat, stopped working by itself and made abnormal noise. 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 the surgical procedure, or if a spare device was available for use. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The date of event was unknown but was known to have occurred in 2022. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The reporter¿s complete facility address was not provided. The actual device was returned for evaluation. The device was evaluated and it was determined that the device had heat, low power, sticky trigger, the locking mechanism was stiff/stuck, and the device made unexpected noise. It was further determined that the device failed pretest for check for sticky triggers, check attachment coupling, and check power with test bench. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to component failure from wear. Udi: (b)(4).
 
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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 Key13367443
MDR Text Key290156782
Report Number8030965-2022-00556
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 Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2022
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 Manufacturer01/25/2022
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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