MAUDE Adverse Event Report: SEASPINE, INC VU APOD PRIME NANOMETALENE HANDHELD GUIDE; DRILL GUIDE

Model Number	33-40-1005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 seaspine was made aware that a 33-40-1005 handheld guide broke during surgery.Additional information was received on (b)(6) 2023 that the surgery could not be completed, and revision is required.All pieces of the instrument were retrieved.No further information on patient condition or revision surgery plan has been received.
Additional Manufacturer Narrative
The 33-40-1005 handheld guide was not returned for analysis.No definitive root cause could be established.No further details have been provided by the reporter.Review of labeling: intraoperative warnings: breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.

• Brand Name: VU APOD PRIME NANOMETALENE HANDHELD GUIDE
• Common Device Name: DRILL GUIDE
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 17599123
• Report Number: 3012120772-2023-00017
• Device Sequence Number: 20688101
• Product Code: MAX
• UDI-Device Identifier: 10889981125974
• UDI-Public: 10889981125974
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210497
• 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): 08/22/2023

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: 33-40-1005
• Device Catalogue Number: 33-40-1005
• Device Lot Number: CR40549E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown