MAUDE Adverse Event Report: PRECISION SPINE, INC SURE-LOK EXTENDED TAB PEDICLE SCREW SYSTEM; K-WIRE

Catalog Number HXI-48-0003

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

B2: other serious or important events - retained foreign object (tip of k-wire left in patient's bone).H3: device evaluation - without the opportunity to examine the remainder of the broken k-wire, no conclusions can be drawn regarding the root cause.Without lot identity, device history review and lot specific complaint history review are not possible.Two-year complaint history review found this to be the only report of breakage for this part number.No corrective actions are recommended.

Event Description

It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform ti mis ct pedicle screw system.While the surgeon was trying to remove the k-wire, ni blunt/threaded (hxi-48-0003) from the second screw at l4, it broke clean at the "knurled" part from the smooth part.No attempt was made to try to retrieve the broken piece, which remains in the patient's pedicle.More care was taken with the final positioning of the screw to ensure the broken tip did not advance any more with the screw being advanced.The surgery as completed with optimal outcome without delay.The remainder of the k-wire is not available for evaluation.

• Brand Name: SURE-LOK EXTENDED TAB PEDICLE SCREW SYSTEM
• Type of Device: K-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: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 17552763
• MDR Text Key: 321224583
• Report Number: 3005739886-2023-00037
• Device Sequence Number: 1
• Product Code: HXI
• UDI-Device Identifier: 00840019922654
• UDI-Public: 00840019922654
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HXI-48-0003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other