MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72200148
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, when the endobutton attached to the graft was inserted into the femoral, and surgeon pulled thread, ultrabraid x5 was broken.Backup device was available to complete the procedure.No significant delay or patient injuries were reported.
Additional Manufacturer Narrative
Additional information: this event was revisited, and was determined that the event experienced does not contribute to a serious injury or harm to the patient and does not have the potential to cause or contribute to serious injury or death if this failure were to recur.In addition, it did not require medical intervention to preclude damage to a body structure or function.This event was re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: ENDOBUTTON CL ULTRA 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8689007
• Report Number: 1219602-2019-00678
• Device Sequence Number: 14015072
• Product Code: MBI
• UDI-Device Identifier: 03596010597274
• UDI-Public: 03596010597274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72200148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1