MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM PEDICLE SCREW SYSTEM; TAP

Catalog Number	39-SP-0565
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2 - other serious or important medical events - retained foreign object.The broken tip of the tap was left in the patient's pedicle.D4 lot number - unknown.H4 device manufacture date - unknown without lot identification.H3 device evaluation - without the ability to examine the complaint product, no conclusions could be drawn regarding the root cause of the reported issue.Without lot identity, device history record review and lot specific complaint history is not possible.Two-year complaint history review found this to be the only report for this part number.No corrective actions are recommended.Should the product be received a follow-up medwatch report will be filed upon completion of investigation.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024.While tapping the pedicle the pedicle screw tap assembly - 6.5mm (39-sp-0565) tip broke off in the patient's bone with the threads buried.After repeated attempts to remove the tap, it was deemed it could not be safely removed and was left in the patient.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: TAP
• 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: 19521041
• Report Number: 3005739886-2024-00028
• Device Sequence Number: 15556568
• Product Code: HTW
• UDI-Device Identifier: 00840019928663
• UDI-Public: 00840019928663
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/17/2024

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: 39-SP-0565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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