MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that 29 months after a double-bundle acl reconstruction with an endobutton, the patient lacked of full flexion with a deficit of 10-15°.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: evaluation is not possible, as the unknown endobutton device will not be returned.The part and lot number have not been provided making an examination of the manufacturing records prohibitive, however a review of the risk management, labeling and instructions for use documentation was reviewed for this device family and found to contain statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the complaint records was also performed for this device family, which confirmed additional complaints have been reported within the scope of the reported study.The investigation was limited to the information provided.This investigation could not draw any conclusions about the reported event with the limited clinical details provided.If additional clinical details become available in the future, the investigation will be reopened.This complaint was reported from the literature review.The study suggest that the superiority of the double bundle might in part be due to the anatomical placement of the femoral fixation obtained using the anteromedial portal for drilling, rather than drilling the femur using the transtibial route in the single bundle groups.During the studying it was reported 29 months following the double-bundle acl reconstruction with and endobutton, the patient lacked of full flexion with a deficit of 10-15°.The patient outcome is unknown.No individual clinical information has been provided for inclusion in this medical investigation, without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Information become available this complaint can be re-assessed.

• Brand Name: ENDOBUTTON
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9745422
• MDR Text Key: 180586470
• Report Number: 1219602-2020-00381
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other,user
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• 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
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other