MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.2MM T-HANDLE TROCAR; PIN, FIXATION, THREADED

Model Number	71674074
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the 3.2mm t-handle trocar confirmed the handle of the device is broken off.The broken piece was not returned with the device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the pro failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Event or Problem Description
It was reported that, during an internal fixation surgery, the 3.2mm t-handle trocar broke.Incident occurred while instrument was outside the patient and no pieces fell into the incision.Surgery was resumed, without any delay, using a back-up device.Patient was not injured as consequence of this problem.

• Brand Name: 3.2MM T-HANDLE TROCAR
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 12800979
• Report Number: 1020279-2021-08105
• Device Sequence Number: 20028212
• Product Code: JDW
• UDI-Device Identifier: 03596010560704
• UDI-Public: 03596010560704
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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 Model Number: 71674074
• Device Catalogue Number: 71674074
• Device Lot Number: 16BCT0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown