MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM NITINOL GUIDEWIRE, BLUNT AND DISPOSABLE 1.45MM; 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	02/16/2023
Type of Reportable Event	Serious Injury
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.Additional narrative: 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.
Event or Problem Description
Device report from synthes reports an event in australia as follows: it was reported that during a procedure on (b)(6) 2023, the surgeon was performing an l4/5 and l5/s1 instrumented fusion with interbody fusions.The surgeon inserted a non-synthes needle followed by a synthes guidewire.It was noted on imaging that a piece of the guidewire had broken off into the vertebral body.The broken material remained in-situ and all implants were successfully implanted and the procedure completed.There was no delay to surgery.This report involves one viper system nitinol guidewire, blunt and disposable 1.45mm.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER SYSTEM NITINOL GUIDEWIRE, BLUNT AND DISPOSABLE 1.45MM
• 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: 16501534
• Report Number: 1526439-2023-00429
• Device Sequence Number: 6297579
• 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
• 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: 02/16/2023
• Initial Report FDA Received Date: 03/08/2023
• 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: BRAINLAB PAC NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown