MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA PRECISION K-WIRE SHARP; INSTRUMENT- KIRSCHNER WIRE

Catalog Number	48230230
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon was passing a precision screw over a guide wire into a pedicle - and once placed, the k-wire was unable to be removed by hand.The surgeon then used a large needle driver to grasp the guidewire, and pulled and backed out the screw at the same time to remove it completely.We then examined the screw and found the tip to be damaged and partially fixed to the wire.The screw and guidewire were replaced and surgery continued, completed successfully.The case was delayed by about 5 minutes while we resolved the issue.The guidewire unfortunately is unable to be returned due to accidentally being thrown away in a sharps bin by a tech on-site prior to my catching it.
Additional Manufacturer Narrative
Risk assessment; the devices were inspected beforehand by the scrub tech visually and functionally, so the deformities had to occur during insertion.Excessive force during insertion would cause the wire to bend and the screw tip to deform.The most likely root cause is the screw was not inserted properly due to excessive force during insertion, causing the k wire to bend inside the cannula and get jammed.
Event or Problem Description
It was reported that; surgeon was passing a precision screw over a guide wire into a pedicle - and once placed, the k-wire was unable to be removed by hand.The surgeon then used a large needle driver to grasp the guidewire, and pulled and backed out the screw at the same time to remove it completely.We then examined the screw and found the tip to be damaged and partially fixed to the wire.The screw and guideire were replaced and surgery continued, completed successfully.The case was delayed by about 5 minutes while we resolved the issue.The guidewire unfortunately is unable to be returned due to accidentally being thrown away in a sharps bin by a tech on-site prior to my catching it.

• Brand Name: XIA PRECISION K-WIRE SHARP
• Common Device Name: INSTRUMENT- KIRSCHNER WIRE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5858421
• Report Number: 0009617544-2016-00328
• Device Sequence Number: 521839
• Product Code: LXH
• UDI-Device Identifier: 07613327265026
• UDI-Public: (01)07613327265026
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2016

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: 48230230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1