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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 Circuit Failure (1089); Overheating of Device (1437); Output below Specifications (3004); Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Concomitant med products: battery casing device 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. Udi ¿ (b)(4).
 
Event Description
It was reported from the (b)(6) that the small battery drive device was faltering (stopping and starting up again) and did not connect to the battery casing sufficiently. It was not reported if the event occurred during a surgical procedure. It was not reported if there was a delay to a planned procedure. It was not reported if there was a spare device available for use. There was no patient involvement reported. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported; however, it was reported that the event occurred in 2020. 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 Key11013391
MDR Text Key228027377
Report Number8030965-2020-09651
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeNL
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 12/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
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 Manufacturer12/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2016
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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