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	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the review of dhr, it was concluded that the product was inspected and accepted for use by quality control department and met all specified parameters of the quality inspection process (qip) with no associated nonconformance.Returned device was visually inspected, functionally tested and the complaint was confirmed.The device tip is missing.The swaging is intact.The condition suggests the swaging yielded to the excessive force.The device otherwise meets dimensional specifications, except for the disassembled and missing tip.The root cause is unknown, but may be the result of surgical technique (excessive torsional force) and possible anatomical conditions, causing seizing of the drill tip in the bone.
Event or Problem Description
Reportedly during decortication of lamina at l4-l5, the orthopedic drill tip fractured off inside the lamina.Surgeon was unsuccessful at retrieving the tip.He elected to leave the device tip in place.He selected a different trajectory around it to complete the spinal fusion case.Bilateral posterior fixation was achieved.

• 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: 17871175
• Report Number: 3004893332-2023-00004
• Device Sequence Number: 5493527
• Product Code: LXH
• UDI-Device Identifier: 00840606158237
• UDI-Public: (01)00840606158237(10)221354(11)211214
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/04/2023

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
• Device Lot Number: 221354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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: 78 YR
• Patient Sex: Male