MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL PEDICLE SCREW 6,5 LG 40; INSTINCT JAVA SYSTEM

Catalog Number	046W0AN26540
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated and the failure of stripped tulip head threads was found, which is in addition to the reported bent.The threads were damaged because the tulip splayed open.The cause of the tulip splaying open is likely attributed to either not using the counter torque wrench, or not having the end of the wrench fully seated over the tulip and against the rod during final tightening.There are no indications of manufacturing issues which would have contributed to this event.
Event or Problem Description
It was reported that during the procedure the tulip head of the screw was widening while the blocker was being installed, causing the blocker to be cross threaded.The damaged screw was removed and replaced with an alternate, while the blocker was successfully reused an implanted properly to complete the case.However, device evaluation by a zimmer biomet employee also found the threads of the tulip head to be damaged in addition to it being bent.

• Brand Name: POLYAXIAL PEDICLE SCREW 6,5 LG 40
• Common Device Name: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 9765102
• Report Number: 3003853072-2020-00004
• Device Sequence Number: 2456238
• Product Code: NKB
• UDI-Device Identifier: 00889024340275
• UDI-Public: (01)00889024340275(10)H33163A(11)190603
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: 046W0AN26540
• Device Lot Number: H33163A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1