MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 1.45 DIA GUIDEWIRE, BLU; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286705220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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 doctor was performing a mis lumbopelvic stabilization procedure for a traumatic sacral fracture.He did this on (b)(6) 2018 and used viper prime for the l5 screw and a viper sai fully threaded screw for the ilium.The construct was a unilateral procedure and was on the right side.Doctor used "jamshidi" needles to create the tracts for his screws.He then inserted 286705220 guidewires and removed the jamshidi needles.He placed the l5 viper prime screw without incident.He then tapped the iliac screw and then placed the viper sai screw.Once the screw was placed where he wanted, he then attempted to remove the guidwire.The guidewire would not move.He used various styles of forceps from the account general spine instruments.Nothing would work.He then asked for a battery powered drill and used a wire driver and placed it on the "stuck" wire.He then used the drill to rotate the guidewire and pulled.After 10-15 seconds, the wire came out, but about 8mm of the distal tip broke off.It appeared as though the broken part of the wire was in the cannulation of the screw.Doctor elected to leave the screw in place.He then successfully completed the procedure.Surgical delay was about 5 minutes.No other information is available.No height or weight is available.Patient consequence? : yes.Patient consequence description:guidewire was stuck.Tip broke off while trying to retrieve.About 8mm of the distal tip remains in the patient.Appears to be within the viper sai screw cannulation.Action taken for procedure:used a small bone drill to try and rotate the wire out.Did not work.The tip of the guidewire broke off.Doctor elected to leave the screw in place.The tip of the guidewire remains in the patient.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: VIPER2 1.45 DIA GUIDEWIRE, BLU
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8016034
• Report Number: 1526439-2018-51021
• Device Sequence Number: 1756037
• Product Code: LXH
• UDI-Device Identifier: 10705034213682
• UDI-Public: (01)10705034213682
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286705220
• Device Catalogue Number: 286705220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 42 YR