MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL BTB 15MM STERILE BX OF1; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203330
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an expired endobutton cl was implanted in the patient.The nurse noticed the incident after the case.No additional harm or infection has been identified with the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: the reported endobutton cl btb 15mm, used in treatment, will not be returned for evaluation.Per the device instructions for use under warnings ¿contents are sterile unless package is opened or damaged.Do not resterilize.For single use only.Discard any open, unused product.Do not use after the expiration date¿.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.This is a complaint from the united states reporting, that an expired endobutton cl was implanted in the patient.The nurse noticed the incident after the case.No additional harm or infection has been identified with the patient.Our records indicate that the product was manufactured in 2013 with an expiration date of june 2018.The information to suggest how long a device is safe once the expiration date has passed is not available.Per the device instructions for use under warnings ¿contents are sterile unless package is opened or damaged.Impact to the patient cannot be determined, however it is expected to be low as long as the packaging was not damaged.In conclusion, based on the available information it cannot be concluded how the expired component date was missed prior to implantation.

• Brand Name: ENDOBUTTON CL BTB 15MM STERILE BX OF1
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9592987
• Report Number: 1219602-2020-00096
• Device Sequence Number: 16236894
• Product Code: MBI
• UDI-Device Identifier: 00885554021738
• UDI-Public: 00885554021738
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 06/30/2018
• Device Model Number: 72203330
• Device Catalogue Number: 72203330
• Device Lot Number: 50463511
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1