MAUDE Adverse Event Report: STRYKER SPINE T-LATCH; DRILL BIT, BONE

Model Number 4100-120

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  malfunction  

Event Description

The drill was taken out to be used when the drill bit fell out.Upon inspection of the drill bit, it was observed that the end of the drill bit had broken off inside of the drill and that is what allowed the other end to fall out.

• Brand Name: T-LATCH
• Type of Device: DRILL BIT, BONE
• Manufacturer (Section D): STRYKER SPINE; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5528622
• MDR Text Key: 41223009
• Report Number: 5528622
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 4100-120
• Device Lot Number: 1230512103
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR