MAUDE Adverse Event Report: DEPUY SPINE INC GUIDEWIRE 0.95MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2020-22-100
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a posterior cervical fusion and a laminoplasty (c1 right lateral mass) for the cervical spondylotic myelopathy on (b)(6) 2023.After c1/2 fusion, brainlab¿s robot and navigation were used to create holes for screw insertion.Then, the guide wire was manually inserted.After the guide wire were inserted into four holes, the hollow tap and the screws were inserted through the guide wire.During screw insertion on the right side of c1, the screw tap was repeatedly moved in and out for directional adjustment several times.When the guide wire was removed after screw insertion, the image showed that guide wire-like of approximately 5 mm to 1 cm.It was confirmed that the guide wire was broken and remained in the body.Removal was impossible due to the position of the guide wire, and the material of the guide wire was nitinol.Therefore, the surgeon decided not to remove the guide wire.The surgery was completed successfully without any surgical delay.The surgeon confirmed by x-ray that the broken guide wire remained in the body.According to the surgeon, the guide wire is for cervical vertebrae and is thin.In addition, the guide wire was broken due to the force exerted on it at a point because the loading and unloading of the instruments and change of direction were performed on several occasions.No further information is available.This report is for one (1) guidewire 0.95mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional narrative: initial reporter is a j&j employee.Complainant part is not expected to be returned for manufacturer review/investigation due to it being implanted.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: GUIDEWIRE 0.95MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16327255
• Report Number: 1526439-2023-00203
• Device Sequence Number: 20978198
• Product Code: LXH
• UDI-Device Identifier: 10705034532608
• UDI-Public: (01)10705034532608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 02/08/2023

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: 2020-22-100
• Device Catalogue Number: 202022100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/08/2023
• 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: UNKNOWN SCREWS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female