MAUDE Adverse Event Report: PRECISION SPINE, INC VARIABLE ANGLE DRILL GUIDE ASSEMBLY

Catalog Number 55-IN-0510

Device Problem Difficult to Advance (2920)

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

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

A visual evaluation of the returned variable angle drill guide identified that is has become disassembled.The pin has moved and is partially blocking the i.D.Of the guide preventing the drill from passing through.The assembly process of the variable angle drill guide involves two items that become encapsulated and retained by a pin that is welded.It appears that the pin may not have been welded on this instrument.The remaining pieces of this lot were evaluated and found to meet specification for the pin and weld.The issue appears to be isolated to one piece of the reported lot.

Event Description

During a procedure performed on or around (b)(6) 2017 utilizing the reform poct occipital system, the occipital drill, straight was not able to pass through the variable angle drill guide assembly (55-in-0510).At his point the doctor chose to switch to a competitive system to complete the procedure.

• Brand Name: VARIABLE ANGLE DRILL GUIDE ASSEMBLY
• Type of Device: DRILL GUIDE
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 6370093
• MDR Text Key: 68747959
• Report Number: 3005739886-2017-00009
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 55-IN-0510
• Device Lot Number: 16067AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention