MAUDE Adverse Event Report: IN2BONES USA COLINK T8 DRIVER

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.

• Brand Name: COLINK T8 DRIVER
• Type of Device: T8 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 Key: 8741463
• MDR Text Key: 199559255
• Report Number: 3011580264-2019-00008
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163293
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: P04 021A01
• Device Lot Number: 0918-P04-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR