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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 Problems Device Stops Intermittently (1599); Mechanical Jam (2983); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Reporter's phone number: (b)(6). The reporter¿s complete address was not provided. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the reported condition was confirmed. It was determined that the trigger was blocked, jammed and was moving heavily. The assignable root cause was determined to be due to premature wear from normal use and servicing. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported from (b)(6) that the small battery drive device made an abnormal and unusual noise/sound. According to the report, the device did not move but once it started to move, it emitted this unusual sound like "kala-kala". 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 a surgical procedure or if a spare device was available. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown but was noted to have occurred in 2018. All available information has been disclosed. If additional information should become available, a supplemental medwatch report 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)
SYNTHES PRODUKTIONS GMBH
hauptstrasse 24
waldenburg 4437
SZ 4437
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7340762
MDR Text Key102448205
Report Number8030965-2018-52062
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
Report Date 02/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.101
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/17/2013
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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