MAUDE Adverse Event Report: ALPHATEC SPINE, INC. BLUNT TIP NITINOL GUIDEWIRE 18" (NITINOL); FZX

Model Number	73770-18-2
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The detached section is approximately.09" in length remains imprisoned within the inner diameter (cannulation) of the polyaxial screw located at the l4.It's manufactured out of nitinol, a shape memory alloy constructed from a combination of nickel and titanium.The nitinol used in the manufacturing of guidewires is processed and certified according to astm f2063 specifications for medical devices & surgical implants.
Event or Problem Description
An international customer ((b)(6)) reported that the surgeon felt strong resistance while attempting to remove the guide wire.The tip broke and was left in the patient as the surgeon pulled with extreme force to extract the instrument.

• Brand Name: BLUNT TIP NITINOL GUIDEWIRE 18" (NITINOL)
• Common Device Name: FZX
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7677392
• Report Number: 2027467-2018-00044
• Device Sequence Number: 1554517
• Product Code: FZX
• UDI-Device Identifier: 00844856057623
• UDI-Public: (01)00844856057623(10)8049101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 73770-18-2
• Device Catalogue Number: 73770-18-2
• Device Lot Number: 8049101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR