MAUDE Adverse Event Report: SMITH & NEPHEW, INC. Q-FIX WITH NEEDLES MINITAPE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205695
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a knee surgery, there was an issue with a q-fix anchor on the inferior patella.Once drilled and cycled, it was tried to put anchor down guide.Inserter was not sliding into the hole.It was drilled again and the surgeon was very conscious of the trajectory inserting the anchor into the hole.The anchor inserter fit into the hole but did not appear all the way down.Although it did not feel all the way down to the surgeon, it felt enough to deploy.It was deployed and it worked and held.Extra drill holes were made in patella from having to re-drill and cycle multiple times.The procedure was completed with the same device.There was a surgical delay of less than 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and 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.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.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 clinical review states the adverse event was likely procedure related and the device had no influence on the event.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h2: corrected data on: d3 (manufacturing name, city and address).This report was inadvertently submitted under manufacturer number ¿3006524618¿, the correct manufacturer number is '1219602¿.

• Brand Name: Q-FIX WITH NEEDLES MINITAPE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• 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: 19520640
• Report Number: 3006524618-2024-00215
• Device Sequence Number: 6171102
• Product Code: MBI
• UDI-Device Identifier: 00885556885642
• UDI-Public: 885556885642
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K231376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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 Catalogue Number: 72205695
• Device Lot Number: 2149513
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/01/2024; 01/28/2025
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/05/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2024
• 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: Other
• Patient Sex: Unknown