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

Model Number	HXX-39-0001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation:other; inventory manager.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 procedure was performed on (b)(6) 2020, to extend the existing construct.While attempting to remove one of the reform pedicle screws, ha coated, the tip of the reform driver with mechanical lock (hxx-39-0001) broke.The surgeon then used the helicopter method to successfully remove the screw.The procedure was successfully completed utilizing the second driver readily available in the set.There was no patient injury or delay to the procedure.
Event or Problem Description
It was reported that a revision procedure was performed on (b)(6) 2020, to extend the existing construct.While attempting to remove one of the reform pedicle screws, ha coated, the tip of the reform driver with mechanical lock (hxx-39-0001) broke.The surgeon then used the helicopter method to successfully remove the screw.The procedure was successfully completed utilizing the second driver readily available in the set.There was no patient injury or delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - the driver was examined by eye as well as with the aid of a 5x loop.The tip is fractured.The fracture is perpendicular to the driver's longitudinal axis.It cannot be ascertained if the fracture was solely due to the forces needed to extract a well fixed ha coated screw or if it was a combination of prior crack initiation and the applied loading condition.Review of device history records (b)(4) found thirteen (13) pieces of lot 00069up were released for distribution on 8/18/2015 with no deviation or anomalies.Complaint history review did not identify a trend for reports of this nature for this part number.The need for corrective action was not indicated.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• MDR Report Key: 10051755
• Report Number: 3005739886-2020-00016
• Device Sequence Number: 19489354
• Product Code: HXX
• UDI-Device Identifier: 00840019928809
• UDI-Public: 00840019928809
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 04/13/2020

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: HXX-39-0001
• Device Catalogue Number: HXX-39-0001
• Device Lot Number: 00069UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR