MAUDE Adverse Event Report: ZIMMER SPINE REDUCTION POLYAXIAL PEDICLE SCREW, DIA 7.5 X 35; INSTINCT JAVA SYSTEM

Catalog Number 046W0AN47535

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that a screw disassembled during surgery.The retention ring broke, allowing the tulip to detach from the screw shaft.The procedure was completed using an alternative screw of the same size.There were no reports of patient injury associated with this event.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The returned screw was evaluated.The screw was found to be disassembled and there was some deformation on the seat.Mechanical testing was performed using a similar screw, and the disassembly could have occurred as a result of using a different screwdriver instead of the required screwdriver.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed, and the instructions state the type of screwdriver which should be used.

• Brand Name: REDUCTION POLYAXIAL PEDICLE SCREW, DIA 7.5 X 35
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6539901
• MDR Text Key: 74325243
• Report Number: 3003853072-2017-00044
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: PK122592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W0AN47535
• Device Lot Number: H19161B
• Other Device ID Number: (01)00889024341142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 58