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

Catalog Number 7210081

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Event 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 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.

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 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
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8176777
• MDR Text Key: 130783246
• Report Number: 1219602-2018-01762
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010496973
• UDI-Public: 03596010496973
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K09155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Catalogue Number: 7210081
• Device Lot Number: 50726680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1