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

Catalog Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that during an acl reconstruction, the endobutton-ecl-btb of the pl bundle graft was flipped within the lateral vastus muscle.The surgeon immediately confirmed the malposition of the endobutton with radiographs during surgery and reduced to an appropriate position by making a small skin incision.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: 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.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 results of the study showed group 2 (ecl-btb) had 11 minutes shorter operation time due to the assistant surgeon being able to start fashioning the hybrid graft immediately after tendon harvest and complete it before the surgeon measures the femoral tunnel length.In the study it was reported that during an acl reconstruction, the endobutton-ecl of the pl bundle graft was flipped within the lateral vastus muscle.The surgeon immediately confirmed the malposition of the endobutton with radiographs during surgery and reduced to an appropriate position by making a small skin incision.After three requests 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.

• 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: 9746707
• MDR Text Key: 182527343
• Report Number: 1219602-2020-00391
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1