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

Model Number	39-SP-0601
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Operator of device - unknown.Occupation - other; quality tech.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
Notification received from the quality tech indicates that the retention bone-screw driver (39-sp-0601) was returned with a broken tip.Attempts to obtain details of how the tip broke have been unsuccessful.No patient or procedure issue have been reported.
Additional Manufacturer Narrative
H3 device evaluation - the driver was examined with the aid of a 5x loop.A fracture of the driver tip is present.The fracture is skewed relative to the driver's longitudinal axis.Multiple fracture planes are present and some shiny fracture surfaces exist.The cause for the failure cannot be determined from the complaint.Potential causes include but are not limited to prior high torque application that initiated a crack which subsequently manifested in a subsequent failure.Review of device history records found (b)(4) pieces of lot 12238ps were released for distribution on 2/7/2017 with no deviation or anomalies.Complaint history review found this to be the only report for this lot.Further review did not identify a trend for reports of this nature for this part number.The need for corrective action was not identified.
Event or Problem Description
Notification received from the quality tech indicates that the retention bone-screw driver (39-sp-0601) was returned with a broken tip.Attempts to obtain details of how the tip broke have been unsuccessful.No patient or procedure issue have been reported.

• 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: 10489748
• Report Number: 3005739886-2020-00024
• Device Sequence Number: 11568569
• Product Code: HXX
• UDI-Device Identifier: 00840019928700
• UDI-Public: 00840019928700
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 39-SP-0601
• Device Catalogue Number: 39-SP-0601
• Device Lot Number: 12238PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1