MAUDE Adverse Event Report: DEPUY SPINE INC CASTLE NUT, REMOVAL SHAFT; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	286725410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2018
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
During a mis procedure, the surgeon was attempting to extract a viper2 inner nut to reposition rod.The nut became stripped.Upon the surgeon¿s attempt to retrieve said inner nut, the tip of the x25 nut inserter broke in the hex of the inner nut.Unable to retrieve, the surgeon opted to leave the nut and the wedged broken tip in the patient to avoid additional issues.Patient consequence? unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

• Brand Name: CASTLE NUT, REMOVAL SHAFT
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7645823
• Report Number: 1526439-2018-50601
• Device Sequence Number: 18877966
• Product Code: GEA
• UDI-Device Identifier: 10705034214399
• UDI-Public: (01)10705034214399
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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 Model Number: 286725410
• Device Catalogue Number: 286725410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR