MAUDE Adverse Event Report: ARTHROCARE CORPORATION UNKNOWN ULTRABUTTON DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Foreign Body Reaction (1868)

Event Date 03/15/2022

Event Type  Injury  

Event Description

It was reported that in literature review "re-rupture rate and the post-surgical meniscal injury after anterior cruciate ligament reconstruction with the press-fit-hybrid®-technique in comparison to the interference screw technique: a retrospective analysis of 200 patients with at least 3 years follow-up"; 1 patient had fever after an acl reconstruction with the press-fit-hybrid®-technique procedure using an ultra-button device.The fever was treated with an arthroscopic irrigation.The patient's outcome is unknown.No further information is available.

Manufacturer Narrative

H10: internal complaint reference (b)(4).Article: volz, r., & borchert, g.H.(2023).Re-rupture rate and the post-surgical meniscal injury after anterior cruciate ligament reconstruction with the press-fit-hybrid®-technique in comparison to the interference screw technique: a retrospective analysis of 200 patients with at least 3 years follow-up.Archives of orthopaedic and trauma surgery, 143(2), 935-949.H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Manufacturer Narrative

H11: corrected information in d3 (manufacturer name, city and address).This report was inadvertently submitted under manufacturer number "1219602", the correct manufacturer number is "3006524618".

Manufacturer Narrative

Corrected data: h6: health effect - clinical code.

• Brand Name: UNKNOWN ULTRABUTTON DEVICE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17514780
• MDR Text Key: 321052974
• Report Number: 1219602-2023-01463
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other