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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 AND ACCESSORY/ATTACHMENT

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SYNTHES GMBH COLIBRI II HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 532.101
Device Problems Noise, Audible (3273); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
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. Device evaluation: the actual device was returned for evaluation. During repair, an evaluation was performed, and it was determined that the initial reported condition of the device working loudly was not confirmed. Therefore, an assignable root cause was not determined. However, the reported condition of sticky trigger identified during service and evaluation was confirmed. The assignable root cause was determined to be due to maintenance. Udi: (b)(4).
 
Event Description
It was reported by (b)(6) that during service and evaluation, it was determined that the trigger of small battery drive device did not move smoothly, the device would not run due to motor damage, and the device had a sticky trigger. It was further determined that the device failed pretest for checking for sticky triggers, checking function of device and checking power with power test bench. It was noted in the service order that the device was loud while working. There were no reports of injuries, surgical delay, 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 AND ACCESSORY/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 Key12585741
MDR Text Key275042255
Report Number8030965-2021-08438
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
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 Manufacturer09/28/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2019
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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