MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48232601

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/11/2016

Event Type  malfunction  

Event Description

It was reported that; surgeon broke 2 vitallium rods while french bending with the rod bender in a scoli case.Surgeon was doing a very gradual bend on the highest setting of the rod bender, was making long sweeping bend, nothing acute.

Manufacturer Narrative

Visual inspection; device history review; complaint history review; risk assessment the returned was confirmed to be fractured upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.The most likely cause of the customer reported event is the presence of voids on the laser marking dots, which were positioned on the tensile side of the rod bend.

Event Description

It was reported that; surgeon broke 2 vitallium rods while french bending with the rod bender in a scoli case.Surgeon was doing a very gradual bend on the highest setting of the rod bender, was making long sweeping bend, nothing accute.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5413010
• MDR Text Key: 38133813
• Report Number: 3005525032-2016-00017
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48232601
• Device Lot Number: MAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1