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

Catalog Number	39-SP-0700
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other: distributor.The driver tip was examined with the aid of a 5x loop.The fractured surface is primarily planar and perpendicular to the driver's longitudinal axis.It is not clear if a crack had preexisted as a result of prior high force application or if the fracture was solely due to high force application due to the hard bone that was encountered.Review of device history record found a total of (b)(4) pieces of lot 33611mm were released for distribution on 9/16/2015 with no deviation or anomalies.Two-year complaint history review (9.24.2017-9.24.2019) found this to be the only report of this nature for this lot.No corrective action is being recommended since design changes to increase breakage resistance were previously implemented.
Event or Problem Description
It was reported that during a fusion procedure performed in (b)(6) on or around (b)(6) 2019, utilizing the reform pedicle screw system, the tip of the reform polyaxial driver (39-sp-0700) broke while inserting 7.5mm reform pedicle screw.The tip of the driver was easily removed and the procedure completed utilizing another driver readily available in the set, with no patient injury and a one minute delay.Information provided indicates that the patient had particularly hard bone.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9202547
• Report Number: 3005739886-2019-00044
• Device Sequence Number: 2490718
• Product Code: HXX
• UDI-Device Identifier: 00840019928731
• UDI-Public: 00840019928731
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 39-SP-0700
• Device Lot Number: 33611MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1