MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	T073-0500-475
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complainant reported that the distal end of a 4.75mm tap broke during surgery.The instrument was no longer needed for surgery after the deficiency was identified.There were no reported patient complications.A visual assessment of the instrument confirmed the reported complaint.The distal tip of all three tap flutes were broken from the instrument.The instrument is intended to measure 9.75" in length, the returned tap measured 9.71" in length.A functionality assessment could not be performed due to the damage to the distal end of the tap.A dhr review was performed for the instrument and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory on (b)(6) 2014.The root cause of the tap breaking could not be reliably determined.It may be possible that the distal tip of the tap was broken due to very dense patient bone.
Event or Problem Description
A complainant reported that the distal end of a 4.75mm tap broke during surgery.The instrument was no longer needed for surgery after the deficiency was identified.There were no reported patient complications.

• Brand Name: XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8893340
• Report Number: 3005031160-2019-00040
• Device Sequence Number: 13532727
• Product Code: HWX
• UDI-Device Identifier: M697T07305004751
• UDI-Public: M697T07305004751
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K152132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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: Health Professional
• Device Model Number: T073-0500-475
• Device Lot Number: 45682-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other