MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM DRIVER WITH MECHANICAL LOCK; SCREWDRIVER

Catalog Number HXX-39-0001

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Impaired Healing (2378)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information - unknown.Occupation - other: sales representative.Evaluation - review of device history records found (b)(4) pieces of lot 0193up were released for distribution on (b)(6) 2016 with no deviation or anomalies that would relate to the reported event.(b)(4).Upon receipt of device and completion of investigation a follow-up medwatch report will be submitted.

Event Description

Information received from the sales representative reports that a revision procedure was performed by on (b)(6) 2019, to address non-fusion, utilizing the reform pedicle screw system.A 6.5 x 35 screw was removed and upon attempted insertion of 7.5 x 35 reform pedicle screw, the tip of the reform driver with mechanical lock (hxx-39-0001) snapped off.The tip was retrieved and the procedure was completed utilizing the second driver readily available in the set.There was no patient injury or delay to the procedure.

Event Description

Information received from the sales representative reports that a revision procedure was performed on (b)(6) 2019, to address non-fusion.The revision was performed utilizing the reform pedical screw system.A 6.5 x 35 screw was removed and upon attempted insertion of 7.5 x 35 reform pedicle screw the tip of the reform driver with mechanical lock (hxx-39-0001) snapped off.The tip was retrieved and the procedure was completed utilizing the second driver readily available in the set.There was no patient injury or delay to the procedure.

Manufacturer Narrative

H3 device evaluation - the tip of the driver is fractured in a plane that is normal to the driver's longitudinal axis.This failure mode is indicative of a torsional overload condition.It is unclear what was done to insert the screw with the other screwdriver since high loading would also be expected unless something were changed.The cause appears to be from high torque application.No corrective actions are being recommended.

• Brand Name: REFORM DRIVER WITH MECHANICAL LOCK
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 8739230
• MDR Text Key: 151424138
• Report Number: 3005739886-2019-00016
• Device Sequence Number: 1
• Product Code: HXX
• 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,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HXX-39-0001
• Device Lot Number: 00193UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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