MAUDE Adverse Event Report: TRIMED, INC. NITINOL STAPLE

Model Number ES-10X10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 04/24/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 it was reported to trimed that there was a incident of infection related to a surgery that involved the trimed nitinol staple.On (b)(6) trimed was given more information on the incident, and that there were seven staples involved in the one incident of infection.There were a total of seven staples involved from lots 317003 (quantity 3) and lot 317004 (quantity 4).This incident was discovered at (b)(6) hospital in (b)(6).An active infection was discovered near the surgical site within the first post-operative week.This is the first time this type of incident has been reported to trimed with the concomitant use of the nitinol staple.

• Brand Name: NITINOL STAPLE
• Type of Device: NITINOL STAPLE
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita, ca
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; santa clarita, ca
• Manufacturer Contact: annie cranston ; 27533 avenue hopkins; santa clarita, ca
• MDR Report Key: 7982437
• MDR Text Key: 198489057
• Report Number: 2031009-2018-00026
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00842188108952
• UDI-Public: 00842188108952
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: ES-10X10
• Device Catalogue Number: ES-10X10
• Device Lot Number: 317003
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Female