MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA OFFSET CONNECTOR; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	03820101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the surgeon used the offset connector.He tightened the screw of the offset connector.The screw was broken.Therefore, the surgeon changed the offset connector to brand new product.
Additional Manufacturer Narrative
Lot# 14e516; visual inspection; device history review; complaint history review; risk assessment.The device was inspected and it was found that the securing screw was fractured.No relevant manufacturing issues were identified as all units met stryker specifications.The root cause is too much torsional force was applied to the screw when it was being tightened, causing the fracture.
Event or Problem Description
It was reported that during surgery, the surgeon used the offset connector.He tightened the screw of the offset connector.The screw was broken.Therefore, the surgeon changed the offset connector to brand new product.

• Brand Name: XIA OFFSET CONNECTOR
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6055203
• Report Number: 3005525032-2016-00135
• Device Sequence Number: 867662
• Product Code: KWQ
• UDI-Device Identifier: 04546540148742
• UDI-Public: (01)04546540148742
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2017

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: No Information
• Device Catalogue Number: 03820101
• Device Lot Number: 14E516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1