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

Model Number	39-SP-0700
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2020-00022 / 00023).
Event or Problem Description
Notification received from the quality tech indicates that the polyaxial driver (39-sp-0700) was returned with a broken tip.Attempts to obtain specific information regarding how the tip broke have been unsuccessful.No patient or procedure issues have been reported at this time.
Additional Manufacturer Narrative
A1 patient identifier - incorrect number filed on initial report.Corrected to be 1421 this report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2020-00022-1 / 00023-1).
Event or Problem Description
Notification received from the quality tech indicates that the polyaxial driver (39-sp-0700) was returned with a broken tip.Attempts to obtain specific information regarding how the tip broke have been unsuccessful.No patient or procedure issues have been reported at this time.
Additional Manufacturer Narrative
D4 unique device identifier - corrected h3 device evaluation - the polyaxial driver (39-sp-0700) was visually examined with the aid of a 5x loop.The polyaxial driver's tip is sheared off with the break being normal to the drivers longitudinal axis.The cause for the failure can not be ascertained from the complaint as no details were provided and since the device likely saw many uses over the course of several years.Potential causes are likely related to difficulty in trying to seat screws or trying to redirect screws, but failures may or may not also be related to damage being imparted during prior use.No recommended corrective actions are being made for the 39-sp-0700 lot of parts since these parts have been in use since 2014, the cause does not appear to be manufacturing related, this design has subsequently been replaced by a new design, and the cause for the failure remains unknown.This report is number 1 of 2 mdrs filed for the same event (reference 00023-2).
Event or Problem Description
Notification received from the quality tech indicates that the polyaxial driver (39-sp-0700) was returned with a broken tip.Attempts to obtain specific information regarding how the tip broke have been unsuccessful.No patient or procedure issues have been reported at this time.

• 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: 10488596
• Report Number: 3005739886-2020-00022
• Device Sequence Number: 3203892
• Product Code: HXX
• UDI-Device Identifier: 00840019928731
• UDI-Public: 00840019928731
• 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,Followup
• Report Date (Section B): 08/10/2020

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: No Information
• Device Model Number: 39-SP-0700
• Device Catalogue Number: 39-SP-0700
• Device Lot Number: 3144MMR-R
• 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; 08/10/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/03/2020; 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1