MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-HANDLE; INSTRUMENT, BENDING OR CONTOURING

Model Number 71674576

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Event Description

It was reported that, during a trauma surgery while the instruments were inside of the patient, the lag driver retaining rod assy capture stick caught onto a guide pin and seemed to be defective; the piece on the trigen t-handle was broken in the captures of the screwdriver.There were no pieces broken off inside of the patient.The procedure was successfully completed with no significant delay using a smith and nephew back up device.Patient was not harmed.

Event Description

It was reported that, during a trauma surgery while the instruments were inside of the patient, the lag screw driver (b)(4) capture stick caught onto a guide pin and seemed to be defective; the piece on the t-handle (b)(4) was broken in the captures of the screwdriver.There were no pieces broken off inside of the patient.The procedure was successfully completed with no significant delay using a smith and nephew back up device.Patient was not harmed.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H6: the navio handpiece part number 110137, (b)(6) intended for treatment was returned for evaluation.A relationship between the reported event and the device was not confirmed.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.The handpiece passed the evaluation test with no incident.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, no reasonable contributing factors could be identified based on the received complaint information and investigation results.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

• Brand Name: T-HANDLE
• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11909921
• MDR Text Key: 253536571
• Report Number: 1020279-2021-04872
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 00885556363447
• UDI-Public: 00885556363447
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2021

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
• Device Operator: Health Professional
• Device Model Number: 71674576
• Device Catalogue Number: 71631172
• Device Lot Number: 07DM10354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/31/2021
• Supplement Dates Manufacturer Received: 05/17/2021; 08/03/2021
• Supplement Dates FDA Received: 06/24/2021; 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention