MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI CT MODULAR MIS PEDICLE SCREW; ROD INSERTER

Catalog Number	64-RD-9010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed in australia on (b)(6) 2023, utilizing the reform ti mis ct pedicle screw system.During insertion of a rod, the tip of the rod inserter assembly (b)(6) broke while trying to manipulate it into position.The broken fragment piece was removed from the patient and the procedure was completed as usual as the rod was in place when the tip broke.There was a 5 minute delay to the procedure resulting from the broken instrument.
Additional Manufacturer Narrative
Device evaluation -images of the complaint product were reviewed.The tip of the inserter is missing with a skewed fractured surface observed.Prior testing indicates that medial-lateral torsional moment forces applied to a rod that is fixed is a likely cause for the observed failure.In the test the rod was fixed in a vice and torsional moments applied in a manner that would rotate the rod if it were not held rigidly in place.Damage due to prior high torsional bending moment application can not be ruled out as a potential contributing factor.Review of device history records found thirty-three pieces of lot 18513fr were received from supplier, ferry machine corp, and released for distribution on 5/21/2021 with no deviation or anomalies.No corrective actions are being recommended since design changes have been previously implemented which increase the inserter strength.

• Brand Name: REFORM TI CT MODULAR MIS PEDICLE SCREW
• Common Device Name: ROD INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 18818735
• Report Number: 3005739886-2024-00013
• Device Sequence Number: 4289509
• Product Code: LXH
• UDI-Device Identifier: 00840019942515
• UDI-Public: 00840019942515
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 64-RD-9010
• Device Lot Number: 18513FR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown