MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM PEDICLE SCREW SYSTEM; SCREWDRIVER

Model Number	39-SP-0601
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other: sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that a revision posterior lumbar fusion procedure was performed on (b)(6) 2020, utilizing the reform pedical screw system.Upon attempted removal of a 6.5 x 40mm reform pedicle screw (not ha coated), that was originally implanted on (b)(6) 2018, the tip of the retention bone-screw driver (39-sp-0601) broke and could not be removed from the head of the screw.The doctor then "helicoptered" the screw out and was able to successfully replace with a new screw.This resulted in a ten (10) minute delay to the procedure.The revision was performed due to degeneration around the previous fusion, not to failure of precision spine product.
Additional Manufacturer Narrative
H3 device evaluation - the driver tip was examined by eye as well as with the aid of a 5x loop.The tip fracture surface is at about 45 degrees relative to the driver's longitudinal axis.It is not clear if the failure is solely due to the loading conditions applied in an attempt to remove a well fixed screw, if combined torsional and bending moments were applied that caused the failure, and/or if prior use damage existed that culminated in the subsequent failure.Review of device history records found (b)(4) of lot 0047it were released for distribution on 10/22/2013 with no deviation or anomalies that would related to the reported event.Complaint history review back to the date of manufacture found this to be the only report of this nature for the reported lot.Further review did not identify a trend for reports of this nature for the reported part number.No corrective actions are being recommended since the exact root cause could not be determined, the failure does not appear to be manufacturing related, and there was not trend identified.
Event or Problem Description
It was reported that a revision posterior lumbar fusion procedure was performed on (b)(6) 2020, utilizing the reform pedical screw system.Upon attempted removal of a 6.5 x 40mm reform pedicle screw (not ha coated), that was originally implanted on (b)(6) 2018, the tip of the retention bone-screw driver (39-sp-0601) broke and could not be removed from the head of the screw.The doctor then "helicoptered" the screw out and was able to successfully replace with a new screw.This resulted in a ten (10) minute delay to the procedure.The revision was performed due to degeneration around the previous fusion, not to failure of precision spine product.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9805502
• Report Number: 3005739886-2020-00009
• Device Sequence Number: 2238380
• Product Code: HXX
• UDI-Device Identifier: 00840019928700
• UDI-Public: 00840019928700
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: 39-SP-0601
• Device Catalogue Number: 39-SP-0601
• Device Lot Number: 0047IT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1