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

Model Number	73770-18-2
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The suspect device has not been returned for evaluation nor has the identifying lot number been provided.The fragment which was reported to be irretrievable, is manufactured out of nitinol, a shape memory alloy constructed out of a combination of nickel and titanium.The nitinol used in the manufacturing of guidewires is processed and certified according to astm f2063 specifications.
Event or Problem Description
Atec received medwatch report number mw5085894 from the fda via mail on (b)(6) 2019.The report stated that during a spine procedure, the k-wire being used broke off.Majority of the wire was removed, but a small piece was irretrievable.

• Brand Name: BLUNT TIP NITINOL GUIDEWIRE 18"
• Common Device Name: FZX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8632061
• Report Number: 2027467-2019-00026
• Device Sequence Number: 13946895
• Product Code: FZX
• UDI-Device Identifier: 00844856057623
• UDI-Public: (01)00844856057623
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/22/2019
• 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