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  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that after the transosseous button fixation technique procedure with endobutton, the patient had a device dislocation.Revision surgery was performed for the re-insertion of the endobutton.It is unknown the outcome of the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The unknown endobutton device will not be returned for examination.The investigation was limited to the information provided, as the specific part and lot numbers to review the device history records were not provided.A review of the manufacturing, risk management documents and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.The instruction for use for the endobutton product family were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.In the event additional information is reported the complaint will be reopened.Information obtained from a literature review journal (author, marc banerjee et al) ¿high complication rate following distal biceps re-fixation with cortical button¿, indicates that after the trans-osseous button fixation technique procedure with endobutton, the patient had a device dislocation.Revision surgery was performed for the re-insertion of the endobutton.There is no identifying patient information or supporting relevant clinical documentation provided.Therefore, a clinical assessment is unable to be performed at this time.

• 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: 9745019
• MDR Text Key: 180563366
• Report Number: 1219602-2020-00377
• 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: 04/10/2020

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: 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: 04/06/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other