MAUDE Adverse Event Report: PRECISION SPINE, INC. POLYAXIAL DRIVER, REFORM; MNI, MNH

Catalog Number 39-SP-0700

Device Problems Break (1069); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/22/2015

Event Type  Injury  

Event Description

It was reported that during a procedure performed on (b)(6) 2015, the tip of the 39-sp-0700 reform polyaxial driver broke during insertion of an 8.5mm x 60mm reform polyaxial screw.The tip was retained in the head of the screw which remains implanted in the patient.Another driver was available to complete the procedure with no delay.

Manufacturer Narrative

This event is being reported as a serious injury due to the fractured driver tip being left in the head of the polyaxial screw implanted in the patient.It is important to note that once the rod implant is seated and locked into the tulip of the polyaxial screw, the fractured tip is prevented from dislodging as long as the rod remains firmly locked in place.Engineering evaluation of the returned device determined the root cause of the tip fracture is attributed to the driver not being fully seated in the polyaxial screwdriver at the time of fracture.The plastic outer sleeve of the assembly has been modified to mitigate the occurrence of the user unthreading the outer secure shaft from the tulip.This change was implemented on 4/4/2014.Additionally, a design change on the thread-form of the reform polyaxial screw was implemented 10/31/2014, to reduce the amount of thread-washout, thus reducing the insertion torque, to mitigate failures due to the aforementioned condition.The reported lot number was manufactured prior to both of these changes.Review of manufacturing history records found (b)(4) units of this lot were released for distribution on 1/5/2014.A 2-year complaint history review found (b)(4) previous reports for tip fracture on this lot.

• Brand Name: POLYAXIAL DRIVER, REFORM
• Type of Device: MNI, MNH
• Manufacturer (Section D): PRECISION SPINE, INC.; pearl MS
• Manufacturer Contact: 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 4784841
• MDR Text Key: 5856626
• Report Number: 3005739886-2015-00051
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39-SP-0700
• Device Lot Number: 3155MM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other