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

Catalog Number	HXI-48-0003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005739886-2023-00037
• Device Sequence Number: 11991260
• Product Code: HXI
• UDI-Device Identifier: 00840019922654
• UDI-Public: 00840019922654
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: HXI-48-0003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown