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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.
 
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Brand NameCOLAG T15 DRIVER
Type of DeviceT15 DRIVER
Manufacturer (Section D)
IN2BONES USA
6000 poplar ave
suite 115
memphis TN 38119
Manufacturer (Section G)
IN2BONES USA
6000 poplar ave
suite 115
memphis TN 38119
Manufacturer Contact
cristi mann
6000 poplar ave
suite 115
memphis, TN 38119
9012607931
MDR Report Key8781861
MDR Text Key150998420
Report Number3011580264-2019-00009
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP06 034A01
Device Lot Number0217-P06-08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Device Age2 YR
Event Location Hospital
Date Manufacturer Received06/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2017
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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