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

Model Number	71674576
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Additional 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
• Common Device Name: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11909921
• Report Number: 1020279-2021-04872
• Device Sequence Number: 4395363
• Product Code: HXP
• UDI-Device Identifier: 00885556363447
• UDI-Public: 00885556363447
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 08/03/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 06/24/2021; 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention