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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IN2BONES USA COLINK T8 DRIVER

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IN2BONES USA COLINK T8 DRIVER Back to Search Results
Model Number P04 021A01
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/05/2019
Event Type  malfunction  
Event Description
It was reported that during a case, upon insertion of the final screw into the mtp plate, that a t8 driver snapped at the tip. The head of the driver remains embedded in the 3. 0mm non-locking screw in the patient. The distributor stated that the surgeon followed all of the appropriate steps and that there were no defects noted with the driver at the start of the case. It was noted that the patient had quite hard bone but no other specific medical conditions. No product was returned for evaluation. No further details are known at this time.
 
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Brand NameCOLINK T8 DRIVER
Type of DeviceT8 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 Key8741463
MDR Text Key199559255
Report Number3011580264-2019-00008
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K163293
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2018
Device Model NumberP04 021A01
Device Lot Number0918-P04-04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Device Age1 YR
Event Location Hospital
Date Manufacturer Received06/12/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2018
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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