MAUDE Adverse Event Report: ZIMMER BIOMET SPINE CANN POLY DUAL LEAD PED SCR TI 6.5X50MM; LANX SPINAL FIXATION SYSTEM

Model Number N/A

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

Event Type  Injury  

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.This is report two of two for this event.Reference report 3004485144-2016-00383.

Event Description

It was reported that a pedicle screw had to be removed from the patient due to the drive tip of a screwdriver breaking off and becoming stuck within the screw during installation.The pedicle screw was replaced with another.There was no 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 examined.A piece of the mating driver had fractured off and was stuck within the screw head, preventing the use of the screw.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.

Manufacturer Narrative

The returned screw was examined.A tip from the driver was not found within the screw head.However, there was damage to the slots within the screw head where the driver tips mate.This deformation is consistent with high torque applications during screw insertion and removal.Possible causes for the high torque include failure to tap, undertapping for the size of screw used, or hard bone.

• Brand Name: CANN POLY DUAL LEAD PED SCR TI 6.5X50MM
• Type of Device: LANX SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: geoffrey gannon ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6178296
• MDR Text Key: 62519627
• Report Number: 3004485144-2016-00384
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7740-6550
• Device Lot Number: JP00866
• Other Device ID Number: (01)00888480545293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 52 YR