MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON,CL ULTRA, 20MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72200147
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery while implanting the tunnel, the cluster of the loop broke.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
One 20mm cl ultra endobutton was returned for evaluation.Visual assessment of the device confirmed the cl (continuous loop) has broken.The break area is a clean cut.Examination of the endobutton showed it is marred removing some of the coating.No burrs or sharp edges were observed that could have contributed to the failure of the cl.This investigation could not identify any evidence of product contribution to the reported complaint.
Event or Problem Description
It was reported that during the surgery while implanting the tunnel, the cluster of the loop broke.No additional bone hole was made and the pieces were removed from patient.A backup device was available to complete the procedure with no significant delay or patient injuries.

• Brand Name: ENDOBUTTON,CL ULTRA, 20MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8214553
• Report Number: 1219602-2019-00026
• Device Sequence Number: 16194860
• Product Code: MBI
• UDI-Device Identifier: 03596010597267
• UDI-Public: 03596010597267
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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 Expiration Date: 10/11/2021
• Device Catalogue Number: 72200147
• Device Lot Number: 50625066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 62