MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDBUTN CL BTB STERILE 25MM BOX OF 1; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	7210081
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, a delay of less than 30 minutes was caused because a foreign substance (like a hair) was found inside the sterile package.A backup device was available to complete the procedure with no patient injuries.
Event or Problem Description
It was reported that during surgery, a delay of less than 30 minutes was caused because a foreign substance (like a hair) was found inside the sterile package.The device was used on the patient.A backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be 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.Additional information.
Event or Problem Description
It was reported that during surgery, a delay of less than 30 minutes was caused because a foreign substance (like a hair) was found inside the sterile package.The affected product was not implanted.A backup device was available to complete the procedure with no patient injuries.

• Brand Name: ENDBUTN CL BTB STERILE 25MM BOX OF 1
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8176777
• Report Number: 1219602-2018-01762
• Device Sequence Number: 19409876
• Product Code: MBI
• UDI-Device Identifier: 03596010496973
• UDI-Public: 03596010496973
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K09155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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: 04/11/2023
• Device Catalogue Number: 7210081
• Device Lot Number: 50726680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 01/08/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 12/27/2018; 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1