MAUDE Adverse Event Report: PRECISION SPINE, INC POLYAXIAL DRIVER, REFORM; SCREWDRIVER

Catalog Number 39-SP-0700

Device Problems Break (1069); Sticking (1597)

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

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

Upon completion of evaluation a follow-up medwatch report will be submitted this report is number 1 of 2 mdr's filed for the same event (reference 3005739886-2015-00104 and 00105).

Event Description

It was reported that during a procedure performed on (b)(6) 2015 the tip of two reform polyaxial drivers broke while implanting reform 8.5 x 50mm polyaxial pedicle screws.Both screws were removed and replaced as the tip was stuck in the head of the screw.There was no delay to the procedure reported.

Manufacturer Narrative

Leading to failure of the driver tip.This overload could be contributed to the diameter and/or length of the screw chosen for the anatomy, and could additionally be dependent on patient bone quality and screw trajectory within the anatomy.Review of manufacturing history records found a total of 13 pieces of lot 3341mm were released for distribution with no deviation or anomalies.A two-year complaint history review found this to be the first report of tip fracture for the reported lot.There has been a design improvement made to the reform pedicle screws to reduce the insertion torque associated with the "wash-out" of the thread-form.The screws being implanted when the drivers broke were identified to be manufactured prior to this change.There have been no reports of driver tip failure associated with screws manufactured subsequent to this design change.Although the need for further corrective action was not indicated, engineering will explore the potential of modifying the material for the drive feature of the 39-sp-0700 to mp35n, in effort to increase the strength of the tip.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2015-00104-1 / 00105-1).

Event Description

It was reported that during a procedure performed on (b)(6) 2015 the tip of two reform polyaxial drivers broke while implanting reform 8.5 x 50mm polyaxial pedicle screws.Both screws were removed and replaced as the tip was stuck in the head of the screw.There was no delay to the procedure reported.

• Brand Name: POLYAXIAL DRIVER, REFORM
• Type of Device: SCREWDRIVER
• 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: 5291271
• MDR Text Key: 33348563
• Report Number: 3005739886-2015-00104
• Device Sequence Number: 1
• Product Code: HXX
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 39-SP-0700
• Device Lot Number: 3341MM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2015
• 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): Required Intervention