MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM GUIDEWIRE, BLUNT AND DISPOSABLE 1.45MM; MISC ORTHO SURGICAL INSTR

Catalog Number	286705220
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1 initial reporter facility name: (b)(6).E3: reporter is a j&j employee.H3, h4, h6: 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
It was reported that on (b)(6) 2024, during a vbs (th12) for fracture, for 1above1below fusion case, when inserting a screw, the guidewire in question was used.The cement and the tip of the guidewire adhered, making extraction difficult.The primary surgeon attempted to remove the cement lump by cutting it off with the tip of the screw or a tap, but was unable to do so, so the 4 cm tip of the guidewire was cut with a hospital instrument and the relevant portion was left in the hollow of the screw.The cut guidewire was sandwiched between the vbs cement mass and the rod and was determined not to move within the body.The surgery was completed successfully with 30 minutes surgical delay.The surgeon commented that the guidewire was inserted into the cement mass for a certain amount of time, which was the cause of this event.This report involves one (1) viper system guidewire, blunt and disposable 1.45mm.This is report 1 of 1 for (b)(4).This report is related to (b)(4), which captures the cement involved in the incident.

• Brand Name: VIPER SYSTEM GUIDEWIRE, BLUNT AND DISPOSABLE 1.45MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• 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: 19380459
• Report Number: 1526439-2024-01568
• Device Sequence Number: 7528698
• Product Code: LXH
• UDI-Device Identifier: 10705034213682
• UDI-Public: 10705034213682
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 286705220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: (SYNTHES SPINE): CEMENT.; UNKNOWN SCREWS.
• Patient Sex: Unknown