MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. TI6 DIGITAL SCREW 2.0 X 30MM; SCREW, FIXATION, BONE

Model Number	DS2030
Medical Device Problem Codes	Material Disintegration (1177); Flaked (1246)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during surgery, upon final tightening of one (1) ti6 digital screw 2.0 x 30mm the screw head "disintegrated".Surgeon was unable to engage the screw to advance it further down and unable to get the remainder of the screw out.The physician used a midas rex burr to burr it down enough to where he could close the incision.The dr.Irrigated and retrieved all the metal shavings that he could but some of the patients tissue turned gray from the burr.The procedure was resumed after a non-significant delay, no other complications were reported.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that no supporting clinical documentation was provided for inclusion in this medical investigation; therefore, no clinical factors were found which would have contributed to the event.The product complaint form documented a 0-30 minute surgical delay without patient injury.Since the tip is reportedly retained in the patient¿s bone, micro-motion and/or migration is unlikely; however, no conclusion on the impact of the possible metallic debris can be established.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for ti6 internal fixation system revealed that if unusual resistance or jamming of the screw occurs, do not continue to advance the screw.This has been identified as an instrument use guide for digital fusion ds - series.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, patient anatomy and/or excessive forces.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Corrected data: g3/g4 (pma/510(k) number), h6 (health effect - clinical code, health effect - impact code & medical device problem code).

• Brand Name: TI6 DIGITAL SCREW 2.0 X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17358337
• Report Number: 3002788818-2023-00055
• Device Sequence Number: 15088897
• Product Code: HWC
• UDI-Device Identifier: 00885556835074
• UDI-Public: 00885556835074
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K060026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DS2030
• Device Catalogue Number: DS2030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown