MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION FATHOM C/C BLADE; RETRACTOR BLADE

Model Number	MR2-102050
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mr2-102050 c/c blade, 50-80mm has not been received and therefore could not be evaluated.No definitive root cause could be established at this time.No further details were provided by the reporter.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery utilizing seaspine's fathom pedicle-based retractor composed of mr2-102075 c/c blade, 75-115mm and mr2-102050 c/c blade, 50-80mm.The superior c/c blade broke during use, causing a nut to fall into the surgical site twice.The nut was retrieved without complication.This resulted in a 45 min surgical delay.No additional anesthesia was required, surgery was completed within normal surgical timeframe.Seaspine was made aware of the delay on 6 may 2024.There was no impact to the patient.This report is for the mr2-102050 c/c blade, 50-80mm.
Additional Manufacturer Narrative
The mr2-102050 c/c blade, 50-80mm was returned without the mr2-002035-12 c/c blade gearhead and mr2-002035-13 c/c blade gearhead nut.It is possible the laser beam weld affixing the two broke and/or the mr2-002035-12 c/c blade gearhead pin or threads sheared under extreme distraction force.A definitive root cause could not be determined as the failed components were not returned for evaluation.No further details were provided by the reporter.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery utilizing seaspine's fathom pedicle-based retractor composed of mr2-102075 c/c blade, 75-115mm and mr2-102050 c/c blade, 50-80mm.The superior c/c blade broke during use, causing a nut to fall into the surgical site twice.The nut was retrieved without complication.This resulted in a 45 min surgical delay.No additional anesthesia was required, surgery was completed within normal surgical timeframe.Seaspine was made aware of the delay on 6 may 2024.There was no impact to the patient.This report is for the mr2-102050 c/c blade, 50-80mm.

• Brand Name: FATHOM C/C BLADE
• Common Device Name: RETRACTOR BLADE
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 19378114
• Report Number: 3012120772-2024-00017
• Device Sequence Number: 7549306
• Product Code: GAD
• UDI-Device Identifier: 10889981300067
• UDI-Public: 10889981300067
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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 Model Number: MR2-102050
• Device Catalogue Number: MR2-102050
• Device Lot Number: WT34010A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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: Other
• Patient Sex: Unknown