MAUDE Adverse Event Report: DEPUY SPINE INC 1.45MM NITINOL GUIDEWIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286705320
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in australia as follows: it was reported that the surgeon was performing a l2-sai posterior instrumented fusion at cairns private on the (b)(6) 2022 on patient.A guidewire was inserted so that it could guide the s1 screw but unfortunately the tip of the guidewire broke inside the patient.The broken tip remained insitu in the vertebral body but will need to confirm this.Construct was extended to s2 with an sai screw on both the left and right side.Action taken when event occurred? construct was extended to s2 with an sai screw on both the left and right side.Fragments were generated but is unknown if the tip was retained in the body.Is unknown is procedure was successfully completed.Concomitant device reported: unknown screws (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) 1.45mm nitinol guidewire blunt.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.45MM NITINOL GUIDEWIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15991085
• Report Number: 1526439-2022-02142
• Device Sequence Number: 5672707
• Product Code: LXH
• UDI-Device Identifier: 10705034507859
• UDI-Public: (01)10705034507859
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 286705320
• Device Catalogue Number: 286705320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Unknown