MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMALL T-HANDLE {} QUICK COUPLING; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	71173542
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handle broke while inserting a trocar.An identical backup device was used to complete the procedure.Surgery time was not extended more than 30 min.The patient or surgical procedure was not affected in any way due to the problem.No broken pieces fell into the patient¿s wound.There are no photos available.Lot number is not available.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting.The information states that the device did not break above the incision, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SMALL T-HANDLE {} QUICK COUPLING
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8739314
• Report Number: 1020279-2019-02478
• Device Sequence Number: 2637714
• Product Code: KTT
• UDI-Device Identifier: 03596010519689
• UDI-Public: 03596010519689
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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 Catalogue Number: 71173542
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1