MAUDE Adverse Event Report: STRYKER SPINE-US 6.0 XIA SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK_SPN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Spinal Cord Injury (2432)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Return status of the device is unknown.

Event Description

A physician reported that their colleague was provided the incorrect xia screwdriver for a cross connector during surgery, their hand slipped and, "hit the spinal cord and resulted in a dural tear.".

Event Description

A physician reported that their colleague was provided the incorrect xia screwdriver for a cross connector during surgery, their hand slipped and, "hit the spinal cord and resulted in a dural tear.".

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The wrong device was used by the surgeon, resulting in a dural tear.The surgical technique lists out which instruments to use for each step and the ifu states that these procedures should only be completed by surgeons that have undergone the necessary training.Additionally, the instruments are labelled with the device name and catalog number to easily identify them.The root cause is surgeon error and there is no failure of the device itself.

• Brand Name: 6.0 XIA SCREWDRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10367733
• MDR Text Key: 201700703
• Report Number: 0009617544-2020-00131
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other