MAUDE Adverse Event Report: ARTHROCARE CORPORATION ULTRABUTTON TIB MED ADJ FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an autograft quad acl reconstruction, at the end of the case, the cradle of the tibial ultrabutton pulled through the graft and lost fixation of the button against the bone.Since the tibial ultrabutton ripped out, the dr only used the button from the ub tibia device and tied the sutures to the button., then backed up those sutures with a footprint anchor below the tunnel for the graft.Dr drilled a new bone hole for the footprint anchor.There was a surgical delay of around 15 minutes.Dr is satisfied with the fixation.No further complication were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10 h6: a device deficiency was identified, however the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the material specifications found that found that raw material must comply with smith + nephew standards and specifications and have no burs or sharp edges.A clinical review states undated intraoperative photos were provided for review however they do not indicate a root cause for the reported event.Based on the limited information received the clinical root cause of the reported events could not be determined.No further risk to the patient is anticipated as a result of the additional bone hole.It was noted that the doctor was satisfied with the fixation.Since no further harm is anticipated no further clinical assessment is warranted at this time.No further medical assessment can be rendered at this time.An analysis of the customer provided image found the button from the ub tibia device tied to the sutures on a surgical blanket.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
Corrected data: b1-b2 & h1/h2 (no serious injury pursuant to 21cfr803).

• Brand Name: ULTRABUTTON TIB MED ADJ FIXATION DEV
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16861967
• Report Number: 3006524618-2023-00176
• Device Sequence Number: 17667308
• Product Code: MBI
• UDI-Device Identifier: 00885556817216
• UDI-Public: 885556817216
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 06/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2025
• Device Catalogue Number: 72205601
• Device Lot Number: 2101562
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 09/27/2023; 06/30/2024
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 10/03/2023; 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female