MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL ACP SYSTEM; TEMPORARY FIXATION PIN

Model Number	AP2-100506
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ap2-100506 temporary fixation pin and ap2-100314 admiral acp drill (report #3012120772-2023-00014) were not returned for analysis; however, review of the x-rays provided confirms fragments of the drill and temporary fixation pin remain in the surgical site.Additional detail regarding the surgical technique and/or patient's anatomy has not been made available for consideration.A definitive cause could not be established.Review of qf-10-01 admiral acp system ifu: possible adverse events bending, disassembly, or fracture of components.
Event or Problem Description
On (b)(6) 2023, a patient underwent spinal surgery consisting of seaspine's admiral acp system.During the procedure, an ap2-100506 temporary fixation pin was inserted through a screw hole; the temporary fixation pin was then removed without being aware that the pin had fractured and a fragment was left in the surgical site.The surgeon continued through the procedure by inserting an ap2-100314 admiral acp drill, 14mm into the same screw hole.The acp drill made contact with the temporary fixation pin and created enough friction to cause it to fracture as well.Fragments of both the ap2-100506 temporary fixation pin and the ap2-100314 acp drill remain in-situ.No reports of tissue damage or patient injury was reported and there are no plans for revision or removal at this time.Seaspine was made aware of this incident on (b)(6) 2023.Report # ap2-100506 temporary fixation pin.Report #3012120772-2023-00014 ap2-100314 acp drill.

• Brand Name: ADMIRAL ACP SYSTEM
• Common Device Name: TEMPORARY FIXATION PIN
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7607278399
• MDR Report Key: 17372603
• Report Number: 3012120772-2023-00013
• Device Sequence Number: 20598372
• Product Code: KWQ
• UDI-Device Identifier: 10889981277109
• UDI-Public: 10889981277109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• 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
• Report Date (Section B): 07/21/2023

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 Model Number: AP2-100506
• Device Catalogue Number: AP2-100506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHORELINE RT; VUMESH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male