MAUDE Adverse Event Report: TRIMED INC NITINOL STAPLE

Model Number	ES-10X10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request.
Event or Problem Description
On may 8th, 2018 it was reported to trimed that there was a incident of infection related to a surgery that involved the trimed nitinol staple.On may 13th, 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 australia.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
• Common Device Name: NITINOL STAPLE
• Manufacturer (Section D): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED INC; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: annie cranston ; 27533 avenue hopkins; santa clarita, CA 91355 ; 6612548485
• MDR Report Key: 7982432
• Report Number: 2031009-2018-00027
• Device Sequence Number: 17677603
• Product Code: JDR
• UDI-Device Identifier: 00842188108952
• UDI-Public: 00842188108952
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/18/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female