MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200146
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl surgery, the endobutton string appeared to have been weak and ripped prior to insertion into patient.The procedure was completed without significant delay (5 minutes) using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported 15mm ultra endobutton cl, intended for use in treatment, will not be returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the suture ripped during use.An exact root cause cannot be determined with confidence without the return of the device; however, factors that could have contributed to the reported event include: excessive force applied during graft passage.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: ENDOBUTTON CL ULTRA 15MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 10038796
• Report Number: 1219602-2020-00749
• Device Sequence Number: 11509829
• Product Code: MBI
• UDI-Device Identifier: 03596010597250
• UDI-Public: 03596010597250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2024
• Device Model Number: 72200146
• Device Catalogue Number: 72200146
• Device Lot Number: 2032611
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1