MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC STREAMLINE MIS SPINAL FIXATION SYSTEM; TAP, BONE

Model Number	04-CANNTAP-55
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a minimally invasive spine surgery with a modified transforaminal lumbar interbody fusion placement using a mis approach.During the procedure, while being used over a guidewire, the distal tip of the cannulated tap fractured off the tip and was successfully recovered without incident.An alternate instrument was used to finish the procedure that resulted in a thirty (30) minute delay.There were no known patient complications associated with this complaint.No additional information is available.
Additional Manufacturer Narrative
A visual assessment of the returned system inserter/compressor showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal tip of the instrument was fractured as reported, both portions of the instrument were returned to the manufacturer for assessment.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable inventory.A dhr review was performed for the instrument lot which met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 09/18/2020, resulting in an approximate field life of 4 years.It is unknown how many uses the device has undergone during that time.It may be possible for this instrument to break when preparing patient bone if it was inadvertently shifted out of alignment while tapping the drilled patient bone.There have been one other complaints of similar nature for this instrument in the past 12 months.The manufacturer will continue to monitor the field for complaints of fractured cannulated taps.

• Brand Name: STREAMLINE MIS SPINAL FIXATION SYSTEM
• Common Device Name: TAP, BONE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 20041542
• Report Number: 3005031160-2024-00029
• Device Sequence Number: 7977589
• Product Code: HWX
• UDI-Device Identifier: 00846468050245
• UDI-Public: 00846468050245
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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: 04-CANNTAP-55
• Device Lot Number: 379066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female