MAUDE Adverse Event Report: PRECISION SPINE, INC LONG K-WIRE- NITINOL; PASSER, WIRE

Catalog Number 48-9016

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

Other serious (important medical event) - this event was assessed as a serious injury due to the tip of the k-wire being left in the patient's bone.Retained foreign object.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.

Event Description

It was reported that during a procedure performed on (b)(6) 2016 the tip broke off the long k-wire, nitinol (48-9016) and was left in the vertebral body of the patient.The procedure was completed with no further issue and no delay.

Manufacturer Narrative

The cause of the tip breakage was most probably due to the k-wire not being removed after seating the screw which caused the k-wire to be impinged and caught in the screw making it difficult to remove.Reviewing the material certifications has determined that the material on the nitinol k-wire is astm 2063.This is an implantable grade of nitinol.Further review of the surgical technique describes to remove the k-wire once the screw is seated in the pedicle to prevent bending or impingement of the wire.This should be done prior to removing the screw driver.Review of manufacturing history record found a total of (b)(4) pieces of lot 1124151 were released for distribution on november 25, 2015 with no deviation or anomalies.A two-year complaint history review found this to be the first report received for this part number.As the root cause is likely related to surgical technique, and there is not a trend for reports of this nature, the need for corrective action was not indicated.

• Brand Name: LONG K-WIRE- NITINOL
• Type of Device: PASSER, WIRE
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 5442499
• MDR Text Key: 38413101
• Report Number: 3005739886-2016-00006
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 48-9016
• Device Lot Number: 1124151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other