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	02/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 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 released for distribution on 5/21/2021 with no deviation or anomalies.No corrective actions are being recommended since design changes were previously implemented which increase the inserter strength.
Event or Problem Description
It was reported that a procedure was performed in (b)(6) on (b)(6), utilizing the reform ti mis ct pedicle screw system.During insertion of a rod, the tip of the rod inserter assembly (64-rd-9010) broke while trying to manipulate it into position.The procedure was completed as usual as the rod was in place when the tip broke.There was a 5-10 minute delay to the procedure resulting from the broken instrument.A second surgery was performed on an unknown date to recover the broken fragment from the patient.

• 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: 18817676
• Report Number: 3005739886-2024-00012
• Device Sequence Number: 4324921
• 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