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

Catalog Number 7207324

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 11/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that after one week of an anatomic double-bundle acl reconstruction with an autologous semitendinosus tendon, the patient radiographs revealed an intra-tunnel displacement of the posterolateral endobutton.The patient was treated with a secondary procedure to refixed the endobutton to the surface of the femoral cortex, also an additional knot was made to the sutures to prevent remigration.After the second operation, satisfactory progress had been made as of the one-year follow-up.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Evaluation is not possible, as the 25mm endobutton cl will not be returned.The lot number was not provided making an examination of the manufacturing records prohibitive.A review of the complaint records was performed for this device, which confirmed additional complaints have been reported for this failure mode.The risk management documentation was reviewed and found to contain this failure mode within the risk file.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.Information obtained from a literature review journal (author, yusuke akaoka, md et al) ¿early postoperative intratunnel migration of an endobutton after anatomic double-bundle anterior cruciate ligament reconstruction¿, indicates that after one week of an anatomic double-bundle acl reconstruction with an autologous semitendinosus tendon, the patient radiographs revealed an intra-tunnel displacement of the posterolateral endobutton.The patient was treated with a secondary procedure to refix the endobutton to the surface of the femoral cortex, and an additional knot was made to the sutures to prevent remigration.There is no identifying patient information or supporting relevant clinical documentation provided.Therefore, a clinical assessment is unable to be performed at this time.However, satisfactory progress was reported as of the one-year follow-up.

• 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: 9744149
• MDR Text Key: 180531011
• Report Number: 1219602-2020-00372
• 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,Followup
• Report Date: 04/22/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7207324
• 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: 03/17/2020; 04/20/2020
• Supplement Dates FDA Received: 03/24/2020; 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR