MAUDE Adverse Event Report: SPINAL ELEMENTS, INC ORTHOPEDIC SURGICAL DRILL CARTRIDGE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	75311-095
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly during decortication of lamina at l4-s1, 2 out 5 orthopedic drill tip fractured off inside the lamina.Surgeon was unsuccessful at retrieving two tips.He elected to leave the device tips in place.He selected a different trajectory around it to complete the spinal fusion case.Bilateral posterior fixation was achieved.Reportedly the young patient had very dense posterior bone.
Additional Manufacturer Narrative
Device remains in patient and no evaluation of device can be completed.The root cause is unknown, but may be the result of surgical technique (excessive torsional force) and possible anatomical conditions (dense bone as reported), causing seizing of the drill tip in the bone.

• Brand Name: ORTHOPEDIC SURGICAL DRILL CARTRIDGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose dr; carlsbad, CA 92010
• MDR Report Key: 18340770
• Report Number: 3004893332-2023-00007
• Device Sequence Number: 12447554
• Product Code: LXH
• UDI-Device Identifier: 00840606158237
• UDI-Public: 00840606158237
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

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 Catalogue Number: 75311-095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female