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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IN2BONES USA COLAG T15 DRIVER
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IN2BONES USA COLAG T15 DRIVER Back to Search Results
Model Number P06 034A01
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2019
Event Type  malfunction  
Event Description
It was reported that during a case, using power, where the surgeon was fusing the cc joint, as the surgeon was close to tightening down the 4.0 screw, one of the "wings" at the tip of the driver broke off.The surgeon was able to retrieve the broken piece and procedure was completed with no further complications.
 
Manufacturer Narrative
The driver appeared dirty when received.The tip of the driver was chipped off.Review of the dhr for the device revealed that the driver was made to a previous revision that has since been updated to include a material change to a stronger material.The dhr showed that this driver was initially released in april of 2017 and had likely been in use for approximately 2 years prior to the breakage.No conclusive cause for the reported event can be determined.No further details are known at this time.
 
Event Description
It was reported that during a case, using power, where the surgeon was fusing the cc joint, as the surgeon was close to tightening down the 4.0 screw, one of the "wings" at the tip of the driver broke off.The surgeon was able to retrieve the broken piece and procedure was completed with no further complications.
 
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Brand Name
COLAG T15 DRIVER
Type of Device
T15 DRIVER
Manufacturer (Section D)
IN2BONES USA
6000 poplar ave
suite 115
memphis TN 38119
MDR Report Key8781861
MDR Text Key150998420
Report Number3011580264-2019-00009
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K170518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP06 034A01
Device Lot Number0217-P06-08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Was the Report Sent to FDA? No
Device Age2 YR
Event Location Hospital
Initial Date Manufacturer Received 06/12/2019
Initial Date FDA Received07/11/2019
Supplement Dates Manufacturer Received06/12/2019
Supplement Dates FDA Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age21 YR
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